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  • Regulatory NewsRegulatory News

    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...
  • Regulatory NewsRegulatory News

    Attorneys General Call on FDA to Strengthen Supplement Safeguards

    • 03 June 2015
    • By
    The attorneys general of New York and Indiana are urging the US Food and Drug Administration (FDA) to "overhaul" the way in which it regulates the manufacture of dietary supplements. Background In the US, dietary supplements are defined as an oral product containing a "dietary ingredient," including vitamins, minerals, herbs, botanical ingredients, amino acids or other dietary substance. Despite commonly being used to support consumer health, dietary supplements are re...
  • Regulatory NewsRegulatory News

    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
  • Regulatory NewsRegulatory News

    FDA Guidance Aimed at Helping to Protect Fish from Certain Drug Products

    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls on sponsors of estrogenic, androgenic or thyroid activity drugs to interact with regulators early on in the review process to help assess the potential impact of their drugs on aquatic wildlife. Background FDA's requirements to conduct environmental testing are the result of the National Environmental Policy Act (NEPA) of 1969. The law required federal agencies to determine t...
  • Regulatory NewsRegulatory News

    US FDA Amends eMDR Rules to align with Unique Device Identification Program

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments  to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system. All changes will affect federal regulation 21 CFR Part...
  • Regulatory NewsRegulatory News

    FDA Says it's OK With Modernizing the Clinical Trial Informed Consent Process

    New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process. Background In the US, clinical trials are regulated by FDA and the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Chapter 21, Section 50.25 of the Code of Federal Regulations (...
  • Regulatory NewsRegulatory News

    23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

    Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year. Background FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation , Section 312 (21 CFR 312). The section ...
  • Regulatory NewsRegulatory News

    FDA Updates Adverse Event Reporting Requirements for Tissue, Cellular Products

    When you hear the term "adverse reaction" in the life sciences industry, you're likely to immediately think about pharmaceutical or medical device products. But as a new guidance document from the US Food and Drug Administration (FDA) makes clear, cellular and tissue products are also subject to reporting requirements. Background The new draft guidance document relates to human cells, tissues and cellular and tissue-based products—better known by their acronym, HCT/Ps. ...
  • Feature ArticlesFeature Articles

    21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

    Introduction 1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development. It was around th...
  • Regulatory NewsRegulatory News

    It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year. According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus , the number of regulatory requirements...