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8.4: More Regulations - Biology

8.4: More Regulations - Biology



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Medical Device Labeling

Any label or written material on the device or material that accompanies the device. Labeling must have adequate directions for use, proper operating instructions, and warnings where the device's use may be dangerous. To learn more about device labeling: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm

Labeling Enforcement

FDA can enforce labeling violations through Notices of Violation (NOVs), Warning Letters, or judicial action (consent decrees, injunctions, and seizures). The FDA looks at a company's website, videos, commercials, brochures, bulk mailings, and press releases to determine if there is any misrepresentation of labeling a device. The FDA responds to violations with the least stringent action depending on the potential to jeopardize public health.

Misbranding

Section 502 of the FFDCA contains provisions on misbranding and false or misleading labeling. A device is considered misbranded if it is false or misleading in any way and if it does not include adequate directions for use. Other examples of misbranding from the FDA website:

  • It is in package form, and its label fails to contain the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the contents regarding weight, measure, or numerical count;
  • Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;
  • It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling;
  • If the device's established name, its name in an official compendium or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name;
  • If the establishment is not registered with FDA as per Section 510, has no device listed as per section 510(j), or obtained applicable premarket notification clearance as per Section 510(k);
  • If the device is subject to a performance standard and it does not bear the labeling prescribed in that standard" (FDA.gov).

Quality System (QS) Regulation - CFR 820

"CFR 820 covers the design and manufacture of devices sold in the US and is like ISO 13485. Part of this regulation states manufacturing facilities will be inspected by the FDA. The quality system regulation includes requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. Manufacturing facilities undergo FDA inspections to ensure compliance with the QS requirements. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySy stemsRegulations/default.htm

Code of Federal Regulations (CFR) Citations

  • 21 CFR Parts 50, 56, 812: Clinical Studies
  • 21 CFR Part 807
    • Establishment Registration and Listing
    • Premarket Notification [510(k)]
  • 21 CFR Part 814: Premarket Approval (PMA)
  • 21 CFR Part 812: Investigational Device Exemptions
  • 21 CFR Parts 801, 809, 812, 820
    • Medical Device Labeling
  • 21 CFR Part 820: Quality System Regulation
  • 21 CFR Part 821: Tracking Requirements
  • 21 CFR Part 803: Medical Device Reporting

The Flexibility of the QS Regulation

"The QS regulation for devices embraces the same "umbrella'' approach to the CGMP regulation of drugs. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation that apply to their specific products and operations, 21 CFR 820.5 of the QS regulation. Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective. The responsibility for meeting these needs and for having objective evidence of meeting these requirements may not be delegated.

Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality features and to develop and implement specific procedures tailored to their particular processes and devices" (FDA.gov).

International Harmonization

The FDA has been a strong advocate for international harmonization of regulations. They worked in collaboration with the Global Harmonization Taskforce (GHTF) to develop QSR that promotes incorporation of international harmonization. In 2011, the GHTF re-organized to become the International Medical Device Regulators Forum (IMDRF), which includes representatives from the US, Canada, Australia, Brazil, Japan, and Europe. More information can be found here: http://www.imdrf.org/

ISO Device Regulations - ISO 13485

ISO 13485 is the standard for a quality management system for the design and manufacture of medical devices. Although ISO 13485 is a stand-alone document, it is harmonized with ISO 9001 with a few important exceptions: It does not need to demonstrate continual improvement, and it does not have customer satisfaction requirements. What it does have, is a focus on risk management and design control, which is essential for device manufacturing. ISO 3485 also includes inspection and traceability requirements for implantable devices. It promotes awareness of regulatory requirements but also in-line with IMDRF

Post-Marketing Activities

The FDA requires medical device manufacturers to participate in many post-market activities, maintaining a quality system, inspections, post-market surveillance studies, tracking, reporting device malfunctions and injury, and death.

  • Medical Device Reporting (MDR) 21 CFR 803: If a device causes death or serious injury, it must be reported. There are also instances where malfunctions must also be reported and allows the FDA to monitor problems. The report must be made within 30 days, and there is a form and a website called Med Watch.
  • Medical Device Recall: A medical device recall is an action that takes place to address a problem with a medical device that may be in violation of an FDA law. Recalls occur when the device is defective; it causes a risk to health or both. A recall does not necessarily mean the product must be returned, sometimes it just needs to be adjusted, or clarification safety instructions provided. 21 CFR 7 provides guidance so that responsible firms may conduct an active voluntary recall.

Examples of the types of actions that may be considered recalls:

  • Inspecting the device for problems
  • Repairing the device
  • Adjusting settings on the device
  • Re-labeling the device
  • Destroying device
  • Notifying patients of a problem
  • Monitoring patients for health issues

A recall is either a correction or removal of a product. A Correction addresses a problem with a medical device where it is used or sold; a Removal addresses a problem with a medical device by removing it from where it is used or sold. In most cases, a company voluntarily recalls a device on its own. When the company has violated an FDA law, the company must recall the device (correction or removal) and notify the FDA. Legally, the FDA can require a company to recall a device if a company refuses to do so under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA follows in exercising its medical device recall authority under section 518(e) of the FD&C Act. It is important to note that a recall does not include a market withdrawal or a stock recovery. When there is a minor infraction not subject to legal action, the FDA may approve a market withdrawal. In the end, almost all recalls are conducted on a voluntary basis by the manufacturer.

A list of recalls by date, https://www.fda.gov/Safety/Recalls/, and a comprehensive searchable recall device database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

Device recalls following the same general recall procedure as previously discussed for drugs, which includes classification of recall (I, II or III), developing a recall strategy, and providing the FDA with recall status reports. To learn more about Device Recalls, visit the FDA device recall web page, and watch the FDA Video: http://fda.yorkcast.com/webcast/Play/1b95461f64be40ecbe3415195cb394911d


8.4 Measuring Organizational Culture

Which values characterize an organization’s culture? Even though culture may not be immediately observable, identifying a set of values that might be used to describe an organization’s culture helps us identify, measure, and manage culture more effectively. For this purpose, several researchers have proposed various culture typologies. One typology that has received a lot of research attention is the Organizational Culture Profile (OCP) where culture is represented by seven distinct values (Chatman & Jehn, 1991 O’Reilly, et. al., 1991).

Adapted from information in O’Reilly, C. A., III, Chatman, J. A., & Caldwell, D. F. (1991). People and organizational culture: A profile comparison approach to assessing person-organization fit. Academy of Management Journal, 34, 487–516.


Creating Unity and Coherence

Following your outline closely offers you a reasonable guarantee that your writing will stay on purpose and not drift away from the controlling idea. However, when writers are rushed, are tired, or cannot find the right words, their writing may become less than they want it to be. Their writing may no longer be clear and concise, and they may be adding information that is not needed to develop the main idea.

When a piece of writing has unity , all the ideas in each paragraph and in the entire essay clearly belong and are arranged in an order that makes logical sense. When the writing has coherence , the ideas flow smoothly. The wording clearly indicates how one idea leads to another within a paragraph and from paragraph to paragraph.

Reading your writing aloud will often help you find problems with unity and coherence. Listen for the clarity and flow of your ideas. Identify places where you find yourself confused, and write a note to yourself about possible fixes.


Contents

Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions promulgated by a government authority, contractual obligations (for example, contracts between insurers and their insureds [1] ), self-regulation in psychology, social regulation (e.g. norms), co-regulation, third-party regulation, certification, accreditation or market regulation. [2]

State-mandated regulation is government intervention in the private market in an attempt to implement policy and produce outcomes which might not otherwise occur, [3] ranging from consumer protection to faster growth or technological advancement.

The regulations may prescribe or proscribe conduct ("command-and-control" regulation), calibrate incentives ("incentive" regulation), or change preferences ("preferences shaping" regulation). Common examples of regulation include limits on environmental pollution , laws against child labor or other employment regulations, minimum wages laws, regulations requiring truthful labelling of the ingredients in food and drugs, and food and drug safety regulations establishing minimum standards of testing and quality for what can be sold, and zoning and development approvals regulation. Much less common are controls on market entry, or price regulation.

One critical question in regulation is whether the regulator or government has sufficient information to make ex-ante regulation more efficient than ex-post liability for harm and whether industry self-regulation might be preferable. [4] [5] [6] [7] The economics of imposing or removing regulations relating to markets is analysed in empirical legal studies, law and economics, political science, environmental science, health economics, and regulatory economics.

Power to regulate should include the power to enforce regulatory decisions. Monitoring is an important tool used by national regulatory authorities in carrying out the regulated activities. [8]

In some countries (in particular the Scandinavian countries) industrial relations are to a very high degree regulated by the labour market parties themselves (self-regulation) in contrast to state regulation of minimum wages etc. [9]

Reasons Edit

Regulations may create costs as well as benefits and may produce unintended reactivity effects, such as defensive practice. [10] Efficient regulations can be defined as those where total benefits exceed total costs.

Regulations can be advocated for a variety of reasons, including [ citation needed ]

    - regulation due to inefficiency. Intervention due to what economists call market failure.
    • To constrain sellers' options in markets characterized by monopoly
    • As a means to implement collective action, in order to provide public goods
    • To assure adequate information in the market
    • To mitigate undesirable externalities

    The study of formal (legal or official) and informal (extra-legal or unofficial) regulation constitutes one of the central concerns of the sociology of law.

    History Edit

    Regulation of businesses existed in the ancient early Egyptian, Indian, Greek, and Roman civilizations. Standardized weights and measures existed to an extent in the ancient world, and gold may have operated to some degree as an international currency. In China, a national currency system existed and paper currency was invented. Sophisticated law existed in Ancient Rome. In the European Early Middle Ages, law and standardization declined with the Roman Empire, but regulation existed in the form of norms, customs, and privileges this regulation was aided by the unified Christian identity and a sense of honor regarding contracts. [12] : 5

    Modern industrial regulation can be traced to the Railway Regulation Act 1844 in the United Kingdom, and succeeding Acts. Beginning in the late 19th and 20th centuries, much of regulation in the United States was administered and enforced by regulatory agencies which produced their own administrative law and procedures under the authority of statutes. Legislators created these agencies to allow experts in the industry to focus their attention on the issue. At the federal level, one of the earliest institutions was the Interstate Commerce Commission which had its roots in earlier state-based regulatory commissions and agencies. Later agencies include the Federal Trade Commission, Securities and Exchange Commission, Civil Aeronautics Board, and various other institutions. These institutions vary from industry to industry and at the federal and state level. Individual agencies do not necessarily have clear life-cycles or patterns of behavior, and they are influenced heavily by their leadership and staff as well as the organic law creating the agency. In the 1930s, lawmakers believed that unregulated business often led to injustice and inefficiency in the 1960s and 1970s, concern shifted to regulatory capture, which led to extremely detailed laws creating the United States Environmental Protection Agency and Occupational Safety and Health Administration.


    Regulations

    The Office of the Registrar of Regulations is responsible for publishing the monthly Delaware Register of Regulations and the Delaware Administrative Code. The Register of Regulations is an official State publication and is published on the first day of each month throughout the year. The Register is a compilation of all regulatory changes occurring in a given month. Administrative regulations have the force and effect of law. The Register of Regulations provides a single location where people may find emergency, proposed, and final regulations. The Administrative Code is a topically-oriented compilation of all regulations in effect and is the official version of the regulations for the State of Delaware.


    Course Equivalency Tables

    The Academic Policies section of the current Temple Undergraduate Bulletin describes a number of policies that relate to Credit for Prior Learning. Official transcripts for courses from other institutions and official score reports should be sent directly to the Office of Undergraduate Admissions. The Undergraduate Admissions office determines which credits will transfer to the University (See the Admissions: Transfer Credit section of the Undergraduate Bulletin), whereas the academic unit to which the student has been admitted determines how credits will be used to fulfill degree requirements in a student's program of study.

    Temple awards college credits to students who in high school participated in the Advanced Placement program sponsored by the College Examination Board as follows:

    AP Course Title

    Temple Equivalent

    Gen Ed Area*

    GS & GS
    (or GS + Major Requirement)

    Biology 1011 & Biology 1012

    Biology 1111 &Biology 2112

    Chemistry 1031/1033 & Chemistry 1032/1034

    Computer Science Principles

    English Literature & Composition

    Environmental Studies 2002

    German LL Elective & German UL Elective

    Geography & Urban Studies 2002

    Italian Language & Culture

    Italian 2001 & Italian UL Elective

    Physics 1021 & Physics 1022

    Physics C- Electricity and Magnetism

    GB removed effective Spring 2017

    Sp 2016 - Fa 2017: Spanish 1003 & Spanish 2001

    History 1101 & History 1102

    AP Exam FAQ

    Sending Your Scores
    All students must request that their Advanced Placement Exam official test scores be sent to the Office of Undergraduate Admissions. Temple University College Board Code: 2906.

    Temple University may not receive AP Test scores in time for your orientation. Therefore, we cannot guarantee these scores will be posted to your academic history in time for your registration advising appointment, which takes place during orientation.

    Students should discuss all AP exams scores (completed & pending) with Temple academic advisor during their orientation academic advising appointment.

    Academic advisors will review individual student's cases during orientation and recommend Temple courses based on anticipated transfer credit, placement scores and degree requirements.

    AP credit will not be awarded until official score report card is received from College Board.

    Dual Enrollment Credit & AP Coursework
    When students submit dual enrollment credit for an AP course on a university or college transcript and also submit scores for the corresponding AP exam, Temple will only award credit based on the evaluation of the dual enrollment credit presented on the university or college transcript.
    Duplicate credit will not be awarded for both the university/college credit and the AP score(s), since according to Temple University policy, students cannot receive credit for the same course twice.

    Placement Assessments
    Since AP scores may not be posted in time for orientation, all incoming first-year students must take placement assessments prior to their first semester - including English, Mathematics, and possibly Foreign Language. Even though students may receive transfer credit for completed and pending AP Exams, successful completion of AP exams does not waive students from taking Placement Assessments.

    • If a student's Math AP scores shows a higher level of math than the math placement results, the AP score will be used to determine the math placement. Please bring a copy of your unofficial AP score with you to orientation.
    • Beginning Spring 2017, students who earn a score of 4 or higher on the AP English Language and Composition exam will be automatically waived from taking English 802: Analytic Reading and Writing at Temple and do not need to complete the English placement assessment.
    • Students who earn credit for the AP English Literature & Composition exam are not waived from taking English 802: Analytic Reading And Writing at Temple and therefore, must complete the English placement assessment.
    • Students can log in to the Online Placement Assessment system to view the list of tests. A red ‘REQUIRED' will be listed next to the tests you are required to complete.

    To learn more about placement assessments, please visit Institution Research and assessment Website: http://atlas.ocis.temple.edu/MarcPlmts/Splash.asp

    AP Credit for Gen ED Requirements:
    Although the AP credits do not transfer as direct equivalents to Temple Gen Ed courses, Temple University will allow students to satisfy the designated Gen Ed area with the AP Credits. Once scores and corresponding transfer credit is posted, students should refer to their Degree Audit Reporting System (DARS) for additional information regarding options for completing remaining GenEd requirements.

    Current students should refer to their DARS for additional information regarding options for completing remaining GenEd requirements.

    * Effective date refers to the semester a student sat for the AP exam. For example, if a note says "Elective prior to Spring 2010", then all students who sat for the AP exam before the Spring 2010 testing date would receive an elective and those who took the exam Spring 2010 or later would receive the new equivalency noted in the 'Temple Equivalent' column.

    ** The same exam is evaluated differently for different exam scores.
    *** Colleges and Schools may have limitations on the type and number of AP credits that can be applied to a degree. For an excel table of School and College specific policies click here or for a pdf version click here.


    Dietary Nitrate from Beetroot Juice for Hypertension: A Systematic Review

    According to current therapeutic approaches, a nitrate-dietary supplementation with beetroot juice (BRJ) is postulated as a nutritional strategy that might help to control arterial blood pressure in healthy subjects, pre-hypertensive population, and even patients diagnosed and treated with drugs. In this sense, a systematic review of random clinical trials (RCTs) published from 2008 to 2018 from PubMed/MEDLINE, ScienceDirect, and manual searches was conducted to identify studies examining the relationship between BRJ and blood pressure. The specific inclusion criteria were: (1) RCTs (2) trials that assessed only the BRJ intake with control group and (3) trials that reported the effects of this intervention on blood pressure. The search identified 11 studies that met the inclusion criteria. This review was able to demonstrate that BRJ supplementation is a cost-effective strategy that might reduce blood pressure in different populations, probably through the nitrate/nitrite/nitric oxide (NO₃ - /NO₂ - /NO) pathway and secondary metabolites found in Beta vulgaris. This easily found and cheap dietary intervention could significantly decrease the risk of suffering cardiovascular events and, in doing so, would help to diminish the mortality rate associated to this pathology. Hence, BRJ supplementation should be promoted as a key component of a healthy lifestyle to control blood pressure in healthy and hypertensive individuals. However, several factors related to BRJ intake (e.g., gender, secondary metabolites present in B. vulgaris, etc.) should be studied more deeply.

    Keywords: Beta vulgaris blood pressure dietary supplements hypertension nitric oxide.


    The Fuzzy Regulations Surrounding DIY Synthetic Biology

    Josiah Zayner is the kind of citizen scientist whom journalists like to write about. He left his job as a NASA biologist to start his own company, the Odin, to sell DIY bio products, like a kit for beginners to learn how to genetically modify bacteria and a more specialized CRISPR kit. In photos, he sports piercings and dyed hair. And, more importantly, he makes glow-in-the-dark beer.

    In early December, Zayner’s company started selling $160 kits for people to make their own glow-in-the-dark beer using a gene from a jellyfish. The Odin aimed to make genetic engineering an affordable part of everyday life. “We see a future in which people are genetically designing the plants they use in their garden, eating yogurt that contains a custom bacterial strain they modified or even someday brewing using an engineered yeast strain,” the website reads.

    But the Food and Drug Administration soon caught wind of Zayner’s product. Soon after the beta release of the fluorescent-beer brewing kit, BuzzFeed reported the FDA reached out to Zayner. The agency, which Zayner hadn’t contacted before selling his product, argued the fluorescence could be classified as a color additive and therefore falls under FDA regulation. Zayner countered that the kits should be safe from regulation because they weren’t directly selling a food product. And he kept selling them.

    He still believes the products themselves don’t fall under FDA regulation, and even though the FDA informed him the marketing of the kits could, he says he hasn’t received any warnings from it since. You can still purchase the kit on the Odin website. “The regulation is super amazing for biohackers, which is surprising,” he told me. “We can sell our CRISPR kits and things and nobody bothers us.”

    At the moment, there is a lot of uncertainty surrounding the regulation of the DIY biology movement. DIY biologists, a subset of the biohacker community, mess around with DNA, often in communal lab settings where they share their techniques, knowledge, and discoveries with other science enthusiasts. As Alyssa Sims noted in Slate in January, “They’re creating spaces to support community engagement with, and the democratization of, science. In effect, then, they are questioning the power, authority, and hierarchy of academic institutions.”

    But with that authority-questioning approach comes sticky questions of legality, ethics, and regulations. According to Gizmodo, in November, officials from Germany’s consumer protection office gathered to discuss the cheap, easy-to-access genetic engineering kits of the type Zayner’s company sells. They concluded they needed to issue a warning, reminding biohackers of a law already on the books that bans genetic engineering experiments outside licensed labs. Biohackers, the government informed them, could face a fine of roughly $55,000 or up to three years in prison.

    It’s not uncommon for European countries to have these licensed-labs laws, Todd Kuiken, a senior research scholar at North Carolina State University’s Genetic Engineering and Society Center, said. (Kuiken warned that Germany should not, however, be taken as a proxy for Europe in general: “In Germany, which has a unique and sordid past with scientific experimentation—you also have to take that into account when it comes to scientists or researchers manipulating genetics.”) There’s been no crackdown, and community labs can themselves apply for licensing, but it’s not as freewheeling as the U.S. regulatory system. In the U.S., practicing DIY biology is, for the most part, perfectly legal. As Sims noted, most abide by a code of ethics, drafted in 2011 by the North American DIYbio Congress, that emphasizes transparency, safety, and responsibility. But those ethics aren’t legally binding.

    The U.S. regulatory system is set up to focus on the products of scientific endeavors, rather than the processes behind them, according to Sarah Carter, a science policy consultant who has helped craft policies for the National Academies of Sciences, Engineering, and Medicine and the National Institutes of Health. Carter calls the product-focused model “the underlying philosophy of the U.S. biotech system.” (One notable exception: If a scientist uses an agrobacterium, a type of bacteria that’s a historically common vehicle for transferring DNA to plants, then she’s treading into regulatory territory for using what the Agriculture Department classifies as a plant pest. Gene guns, which are another common technique for gene-editing plants, do not fall under this regulation.)

    So what’s to stop you from being afraid of deranged basement scientists or incompetent, unsupervised students handling dangerous pathogens? For now, at least, there’s the limitation of the science itself. Genetically engineering something dangerous is high-level science, generally considered too advanced for community labs. Citizen scientists sometimes dream big, but occasionally, the reality of scientific limits can bring those dreams crashing down.

    No story serves as a better warning for the dangers of hyping biohacking too much than its most famous fizzle, the glowing plant project. Three biohackers garnered a lot of hype in 2013 when they vowed to develop genetically modified tobacco plants that glowed in the dark. Through Kickstarter, where they promised to eventually send plants to donors, they raised almost $500,000. People were excited. (Kickstarter was less enthusiastic. Soon after the glowing plant project was funded, Kickstarter updated its rules to say “Projects cannot offer genetically modified organisms as a reward,” though the plant project was grandfathered in.) But the scientific limitations caught up with the project, and in April, the one founder remaining with the project announced that it had run out of money and that the endeavor had ended. Nobody received glowing plants.

    As Dan Grushkin, who runs GenSpace, a community biology lab in New York, wrote in Slate in 2013: “DIYers are a long way from engineering pandemics, which is only possible in sophisticated biolabs, or customizing viral assassins, which is only possible in science fiction.”

    Not much has changed in the past four years. The labs that do handle contagious diseases are tied to larger institutions and funded by grants that stipulate security measures appropriate for the risk level of the pathogens being used, according to Matt Anderson, a biosafety officer at the University of Nebraska–Lincoln who serves as an adviser to DIY biology labs. Those familiar with the work done in the DIY biology community emphasize that these labs aren’t messing around with contagions. DIY biologists often practice self-restraint “because you don’t want too much government scrutiny,” Anderson said. The community biotech labs even follow standard biosafety rules you would find in any university lab.

    Nor is community DIY bio scientifically advanced enough, yet, to fabricate gene drives, a gene-editing technology that passes on the edits to the offspring and spreads them through an entire population. Gene drives are spurring more conversations about the future of genetic engineering regulations. But for the biohacking community, the ability to successfully create gene drives still seems somewhat distant.

    If independent scientists try to sell products created with genetic engineering, however, then regulators can step in. The FDA regulates all genetic modifications to animals like it regulates drugs, and any actual food or drugs have to go through standard regulations. Thus, a dog breeder who tried to genetically engineer healthier Dalmatians ran up against the FDA. But even then, as Zayner with his glowing beer kits learned, there’s some room for debate.

    It’s unlikely any of the hazier areas of biohacking regulation will be ironed out in the near future. With any change in an administration, it can take a while for administrative policies to solidify. Biotechnology is an inherently difficult regulatory area. And according to Carter, the science policy consultant, the many unfilled administrative positions in the regulatory agencies have gridlocked policy development. “Everyone I know is in wait-and-see mode,” she said. “It’s hard to predict how the Trump administration will approach biotechnology. I’m starting to think the Trump administration won’t pay attention at all, and it’ll languish and we’ll be stuck with what we have for four years.”

    This article is part of the synthetic biology installment of Futurography, a series in which Future Tense introduces readers to the technologies that will define tomorrow. Each month, we’ll choose a new technology and break it down. Future Tense is a collaboration among Arizona State University, New America, and Slate.


    A portal site for systems biology.

    *CellDesigner

    CellDesigner TM is a modeling tool of biochemical networks with graphical user interface. It is designed to be SBW (Systems Biology Workbench) compliant, and support SBML (Systems Biology Markup Language) format.

    Models created by CellDesigner:
    EGFR Pathway Map, Molecular Interaction of Macrophage, PANTHER Classification System, Check Model Repositories section under Resources for more.

    CellDesigner 4.4.2 (2019/05/20)

    • macOS Catalina and Ubuntu 18.04 support
    • Plugin APIs enhances
    • BioModels new API support
    • Garuda enabled
    • bug fixes

    Operating Environment:

    CellDesigner 4.4 (2014/07/12)

    ChEBI Database connection support + SBGN-ML Plugin API + library updates (libSBGN-ML + SimulationCore) + connection updates (DBGET + SABIO-RK) + bug fixes.

    Operating Environment:

    CellDesigner 4.3 (2013/02/01)

    CellDesigner 4.3 supports libSedML + libSBGN-ML + SABIO-RK reaction information import function update + bug fixes.

    Operating Environment:

    CellDesigner 4.2 (2011.10.5)

    Features:
    CellDesigner 4.2 supports Reduced Notation + Simulation Parameter Polymorphism, and SBMLsim solver.

    Operating Environment:

    CellDesigner 4.1 (2010.06.30)

    Features:
    CellDesigner 4.1 supports SBML Level 2 Version 4, enabling MIRIAM annotation, export to BioPAX level 3 and SABIO-RK integration.

    CellDesigner 4.1 beta (2009.8.28)

    Features:
    CellDesigner 4.1 beta supports SBML Level 2 Version 4, enabling MIRIAM annotation, and SABIO-RK integration.

    * Please note that this is the beta version, newly implemented features may not be fully functional.
    * If you create/edit a file with this beta version, your model will not be able to open with the lower version of CellDesigner.

    CellDesigner 4.0.1 (2008.8.12)

    Features:
    CellDesigner 4.0.1 is the bug fix version of CellDesigner 4.0. Ver.4.0 enhances Graphical Notation, based on SBGN Level 1 proposal.

    * If you create/edit a file with this new version, your model will not be able to open with the lower version of CellDesigner.
    Please check the file compatibilities.

    CellDesigner 4.0 (2008.8.4)

    Features:
    CellDesigner 4.0 is the enhanced Graphical Notation version, based on SBGN Level 1 proposal. Other new features and updates in CellDesigner 4.0.

    * If you create/edit a file with this new version, your model will not be able to open with the lower version of CellDesigner.
    Please check the file compatibilities.

    NOTICE: (2008/08/08) We have found serious bugs in CellDesigner4.0, and we are preparing the bug fix version now. We would strongly recommend you to wait for the bug fix version 4.0.1. If you want to try 4.0 features, please be aware of the following bugs.

    - Notes data may be lost when saving the file.
    - SBW connection: CellDesigner annotation data is not passed to SBW modules.
    - Database link to Genome Network Platform is not working
    - Incorrect error messages for simulation.

    CellDesigner 4.0beta for Graphical Notation Preview (2007.12.7)

    /> Features:
    CellDesigner 4.0 beta is the enhanced Graphical Notation version, based on SBGN Level 1 draft. There are several new features and changes in CellDesigner 4.0 beta.


    * Please note that this is the beta version, newly implemented features may not be fully functional.
    * If you create/edit a file with this beta version, your model will not be able to open with the lower version of CellDesigner.

    CellDesigner 3.5.2 (2007.11.15)

    Features:
    CellDesigner3.5.2 is the bug fix version of CellDesigner 3.5.1.

    CellDesigner 3.5.1 (2007.1.10)

    Features:
    CellDesigner3.5.1 is the bug fix version of CellDesigner 3.5.

    CellDesigner 3.5 (2006.12.28)

    /> Features:
    CellDesigner 3.5 now supports smooth SBML file handling. Validate and auto-layout when opening a SBML file, simulate and output to PDF for your publication.

    CellDesigner 4.0alpha for Plugin Developer's Preview (2006.10.7)

    Features:
    CellDesigner 4.0 alpha is the Plugin Developer's version. If you can use Eclipse, you can develop your own plugin onto CellDesigner. Other than Plugin function, there are several new features and changes in CellDesigner 4.0 alpha.
    * Please note that this alpha version, newly implemented features may not be fully functional.

    CellDesigner 3.2 (2006.7.5)

    Features:
    CellDesigner3.2 now support libSBML, a standard SBML library. You can handle files smoothly from modelling to simulation. It also supports Java 5 and Intel Mac.

    CellDesigner 3.1 (2006.3.24)

    Features:
    CellDesigner3.1 is the speed up version of CellDesigner 3.0.1.
    Ver.3.1 aims to achieve smoother, user friendly operation: performance tuning for displaying graphics on canvas, navigation using Bird's Eye View, and wheel mouse,and directly import curated models from BioModels.net database.

    CellDesigner 3.0.1 (2006.1.26)

    /> Features:
    CellDesigner3.0.1 is the bug fix version of CellDesigner 3.0.

    CellDesigner 3.0 (2005.10.15)

    Features:
    A new notation that enhanced previous process diagram into gene and RNA, as well as protein complex structure. Version 3.0 implements most part of notations described in Kitano, et al., "Using Process Diagram for Graphical Representation of Biochemical Networks", Nature Biotechnology, August 2005.


    CellDesigner3.0 supports simulation and parameter scan by an
    integration with SBML ODE Solver. By using CellDesigner3.0, you can browse and modify existing SBML models, create a new model with references to existing databases, simulate and view the dynamics through an intuitive graphical interface.

    CellDesigner 2.5 (Released 2005.9.1)

    CellDesigner2.5 supports simulation and parameter scan by an
    integration with SBML ODE Solver. Once you have installed
    CellDesigner2.5, you can browse and modify existing SBML models, simulate and view the dynamics through an intuitive graphical interface. The graphical notation scheme used in CellDesigner is based on a proposal by Kitano, et al. ("Using process diagrams for the graphical representation of biological networks",Nature Biotechnology  23(8), 961 - 966 (2005)).
    By using CellDesigner, you can create your model with references to existing databases, simulate and analyze the dynamics.

    CellDesigner ver3.0 alpha for Graphical Notation Preview (Released 2005.8.4)

    Features:
    CellDesigner 3.0 alpha release is a preview version of umcoming formal release. The intention of this preview release is to provide you with a feel of a new notation that enhanced previous process diagram into gene and RNA, as well as protein complex structure.

    Please note that functions of this preview versiion is substantially restricted as the sole purpose of the alpha release is to show the new notation. Version 3.0 implements most part of notations described in Kitano, et al., "Using Process Diagram for Graphical Representation of Biochemical Networks", Nature Biotechnology, August 2005.

    For any serious work, please use on-going version CellDesigner 2.2 (or 2.5 which will be released shortly).

    Note: you can NOT SAVE YOUR MODEL with this version.
    You can open and edit your SBML model (which includes a model created by CellDesigner 2.x). You can also export your model to image file (JPEG, PNG, SVG) for your publication, CSV and pure SBML file for simulation. The exported pure SBML file doesn't contain graphical information, but other information such as kinetic laws, parameters, initial concentrations etc. are stored.


    Watch the video: Thermoregulation (August 2022).