• Regulatory NewsRegulatory News

    FDA extends comment period on ICH Q12 guidance

    The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.   The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).   FDA announced in a pre-publication notice in the 8 Septembe...
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    FDA says Turkish OTC maker’s testing program earns failing grades

    The US Food and Drug Administration (FDA) criticized a Turkish manufacturer of over-the-counter drugs for failing to test incoming ingredients and to test products before releasing them to the market in a recent warning letter . The company was also warned for its lax approach to stability testing.   The 13 May letter to Istanbul-based Gulsah Uretim Kozmetik Sanayi Anonim Sirketi follows up on FDA’s review of a 23 April response to request for records. The firm is the...
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    News in Focus: PDUFA VII is a step in the right direction for the rare disease community

    Craig Martin is chief executive officer of Global Genes, a nonprofit organization whose mission is to increase public awareness for rare disease and globally connect, empower and educate individuals and rare disease foundations in person, print and online. More than 400 million people worldwide are affected by 7,000+ rare diseases. In the U.S., around 1 in 10 people (more than 33 million Americans) have a rare condition. More than half of rare disease patients are chi...
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    Animal models have limitations for safety assessment of gene therapies: FDA adcomm

    An advisory committee to the US Food and Drug Administration (FDA) has said animal models are “problematic” in assessing the safety risks of gene therapies derived from adeno-associated virus (AAV) vectors.   FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) held a virtual meeting on 2 September to discuss the best animal models to study to assess safety of these products.   “AAV are a popular type of gene therapy, yet we are seeing a variety o...
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    JAK inhibitors' CV, cancer risks merit expanded boxed warning

    The boxed warnings for several members of a class of drugs used to treat a number of inflammatory conditions must be revised to reflect the increased risk of cancer, serious cardiovascular problems and death seen in people taking the drugs, according to a new drug safety communication from the US Food and Drug Administration (FDA).   The revisions come after safety data from a randomized clinical trial of Pfizer’s Xeljanz (tofacitinib) and is extended release formulati...
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    RAPS' LatestRAPS' Latest

    Top FDA and EMA officials to kick off Convergence 2021

    RAPS will hold its annual Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory issues, 12–15 September . Convergence 2021 will be a live, virtual event featuring more than 100 educational sessions, presentations, panel discussions, speaker and author meet and greets, and other interactive sessions with more than 200 expert speakers.   The four-day conference will kick off with an opening plenary and panel discussion o...
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    FDA convenes adcomm for Pfizer COVID booster

    The US Food and Drug Administration (FDA) announced late Wednesday afternoon that it plans to hold an advisory committee meeting on 17 September to discuss a third booster shot of the Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 years and up.   "The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency's advisory committee to inform our decision-making...
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    FDA proposes to refuse Intarcia’s exenatide combo product NDA —again

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has told Intarcia Therapeutics it is proposing to refuse a new drug application for their type 2 diabetes drug-device combination product ITCA 650.   In a notice posted in the Federal Register , the agency said Intarcia can request a hearing from FDA on the proposal, but if the hearing is waived or it is determined the reason for the hearing isn’t sufficient, FDA will move forwa...
  • RoundupsRoundups

    FDA Approvals Roundup: Skytrofa, Invega Hafyera, Briviact

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Skytrofa approved as weekly therapy for children with growth hormone deficiency Ascendis’s  Skytrofa (lonapegsomatropin-tcgd injection) has been approved as a weekly human growth hormone treatment for children aged 1 year or older who have short stature because of growth hormone deficiency.   The approval was based on efficacy findings from a...
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    FDA revises MAPPs on data standards program, scientific interest groups

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) recently issued two revised documents for its Manual of Policies and Procedures (MAPP): one addresses updated procedures for its data standards program and the other covers operational procedures for scientific interest groups (SIG).   The 10-page MAPP on data standards governance discusses the operating model to support the implementation of CDER’s data standards program. It r...
  • ReconRecon

    Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US When Will the Delta Surge End? ( NYT ) Why can’t America fix its Covid-19 testing problems? ( VOX ) Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant ( NPR ) First vaccination doses up 17 percent since Pfizer approval: analysis ( The Hill ) Companies eye financial penalties for unvaccinated workers ( The Hill ) America has waste...
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    Perrigo: Pharmaceutical industry should question nitrosamine risk assessments

    The pharmaceutical industry needs to closely evaluate suppliers’ testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products. Not questioning dubious results can wreak havoc and unnecessarily flag high levels of impurities where none may exist, warned an official from Perrigo at a 31 August webinar.   The focus of the webinar, convened by the International Pharmaceutical Excipients Council (IPEC), focused on a set of best practic...