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  • Regulatory NewsRegulatory News

    Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software

    The US Food and Drug Administration’s (FDA) regulation of prescription drug-use-related software (PDURS) behooves alignment across relevant centers, industry comments on FDA’s proposed framework argued. From pharmaceutical companies and trade associations to digital health companies and coalitions, the agency’s November 2018 proposed framework for the future regulation of PDURS drew comments from a range of stakeholders. The proposed framework  on PDURS is largely seen...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance on Patient Experience Data Incomplete, Critics Argue

    Industry group BIO, the National Association for Rare Disorders (NORD) and the National Center for Health Research (NCHR) called for clarification on how regulators will use draft guidances proposed by external stakeholders on patient experience data. The comments on the US Food and Drug Administration (FDA) draft guidance from December 2018 on developing and submitting proposed draft guidances related to patient experience data showed some consensus around including ...
  • Regulatory NewsRegulatory News

    AdvaMed, MITA Call for Tweaks to CDRH’s Proposed FY 2019 Guidance Development Lists

    Industry groups offered feedback on the lists of guidance the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) proposed to develop during this fiscal year. The comment period on the guidance development lists proposed for medical devices closed earlier this week, with AdvaMed and the Medical Imaging & Technology Alliance (MITA) among those that responded to the October call   for feedback. The groups addressed the list of guida...
  • Regulatory NewsRegulatory News

    FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity

    As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies. Background In January, FDA released its draft guidance on biosimilar interchangeability for consultation, noting that there is "no single data package that will work for all proposed interchangeable pr...
  • Regulatory NewsRegulatory News

    Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance

    Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets. The draft guidance, released in June , comes as FDA has warned that for “numerous approved” chewable tablets, companies have not evaluated critical quality attributes such as hardness, disintegration and dissolution "a...
  • Regulatory NewsRegulatory News

    PhRMA, BIO Call for Global Approach on Regulations Governing Manufacturing Changes

    The US Food and Drug Administration (FDA) should work more closely with the International Conference on Harmonization (ICH) on the reporting of chemistry, manufacturing and controls (CMC) changes for approved drugs and biologics, according to the industry groups’ comments on proposed FDA draft guidance. The FDA draft guidance , known as Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products and released in June, lays out new recommendat...
  • Regulatory NewsRegulatory News

    FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

    As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket. The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals. "In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docke...
  • Industry Weighs in on Expedited Products Guidance, Calling for Definitional Clarity

    In June 2013, the US Food and Drug Administration (FDA) released a long-awaited and much-anticipated guidance document on its new breakthrough product designation , and in the process of doing so overhauled much of its existing guidance on so-called "expedited programs" as well. Now one of the pharmaceutical industry's most prominent groups is weighing in on the topic, saying that while the guidance is "critical," extensive changes to definitions are warranted. Backgrou...
  • Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions

    Australia's Therapeutic Goods Administration (TGA) has released responses submitted to the agency regarding a draft guideline set to change the way the regulator oversees over-the-counter (OTC) medications. The guidance, Australian regulatory guidelines for OTC medicines (ARGOM) , was first published in 2003, and since then has only undergone two minor updates in early 2011. In early 2012, TGA released a major planned update to the ARGOM, including the way it plans to ...
  • Australia Looking to Change Layout of Package Labeling

    Australia's Therapeutic Goods Administration (TGA) is calling for comments on a new proposed review to change the way labeling information is situated on medicinal product packaging. The proposed changes would apply to both over-the-counter (OTC) and prescription products, and are aimed at making the medicines safer to use by making information easier to understand. Before formulating new regulations, TGA is calling for public and industry input on what changes should ...
  • Biotechnology Companies Seek Changes, Clarification in Biosimilar Draft Guidance

    The US Food and Drug Administration's (FDA) draft guidance on biosimilars attracted general praise and some pointed criticism at a public meeting held 11 May as companies jockeyed for more flexibility and clarification, reports Genetic Engineering & Biotechnology News (GEN) . The meeting drew a huge amount of testimony, presentations and general comments from a host of companies and organizations , including Abbott, Amgen, Novo Nordisk, Pfizer, PAREXEL, BIO, Eli ...
  • Biosimilars Guidelines Attract Attention, Criticism

    As Genetic Engineering & Biotechnology News reported in mid-April, the US Food and Drug Administration's (FDA) draft biosimilar regulations attracted mostly negative comments . Now some companies are adding further commentary to the pile-and they're bringing up points of substantial friction with FDA. Pharmaceutical manufacturer Amgen told FDA regulators that "requiring the maintenance of biosimilarity over time would inhibit manufacturing and quality improvem...