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  • Regulatory NewsRegulatory News

    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
  • Regulatory NewsRegulatory News

    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...
  • Regulatory NewsRegulatory News

    CDER Guidance Agenda for 2019: What’s Coming

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019. The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural. The guidance in clinical/medical focuses on specific types of develop...
  • Regulatory NewsRegulatory News

    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
  • Regulatory NewsRegulatory News

    CMC Changes for Biologics: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Based on a tiered-reporting system for specific changes, the 43-page draft provides applicants and manufacturers with general...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • Regulatory NewsRegulatory News

    Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels

    This article summarizes several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule. Introduction On 27 May 2016, the US Food and Drug Administration (FDA) published in the Federal Register its final...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Postapproval Manufacturing Changes China Food and Drug Administration (CFDA) is seeking feedback on its guidance on postapproval manufacturing revisions. The draft texts propose three tiers of changes to production processes and detail the regulatory steps companies need to take in each circumstance. Echoing draft guidance posted by the US...
  • Regulatory NewsRegulatory News

    Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

    Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes for biologics to be documented in annual reports. The draft guidance notes that under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities or responsible personnel that have a ...
  • Regulatory NewsRegulatory News

    FDA Plans to Finalize 510(k) Change Guidances Ahead of November Deadline

    An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act . In August 2016, FDA released the two draft guidances , five years after the agency's first attempt to replace its 1997 guidance on the topic. But, FDA withdrew the 2011 draft guidance after ...
  • Regulatory NewsRegulatory News

    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...