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  • 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    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International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 The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...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    CMC Changes for Biologics: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in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...
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    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...
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    Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017)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 CFDA Posts Draft Guidance on Postapproval Manufacturing Changes China Food and Drug Administration (CFDA) is seeking feedback on its guidance on postapproval manufacturing revisions.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 Echoing draft guidance posted by the US...
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    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 ...
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    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 ...
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    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...
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    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...
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    Australia Proposes New Risk-Based Approach to Medicine Variations

    Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement. "These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before imple...
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    Generic Drug Industry Group Seeks FDA Regulation Changes

    The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...
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    FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines

    The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks. Labels for both codeine and tramadol are being updated to include additional “Contraindications and Warnings.” Among the updates are contraindications for use of codeine or tramadol in all children younger...
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    WHO Releases Draft Guidance on Postmarket Changes to Biologics

    The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment. Specifically, the guideline, which covers both biologics (referred to as biotherapeutic products) and biosimilars (referred to as similar biotherapeutic products (SBPs)), details the procedures and data requirements for a ra...