• FDA shows jump in competitive generic approvals

    The US Food and Drug Administration (FDA) approved a steadily increasing number of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) in FY 2021 while the number of priority generic approvals leveled off, according to agency’s quarterly data on reviews and approvals of priority and competitive generics.   FDA approved 29 priority ANDAs in FY 2021, one more than the 28 approved in  FY 2020 . There was an increase of about 8% in the number of ...
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    Consent decree shuts down Utah herbal firm

    A Utah-based manufacturer and seller of herbal remedies and nutritional supplements has agreed not to market or sell its wares until products and labeling are compliant with federal drug regulations. Acting on behalf of the US Food and Drug Administration (FDA), the Department of Justice filed the complaint that triggered the consent degree of permanent injunction between Grandma’s Herbs, Inc., its owners, and the US government. The consent decree was entered by the US Dis...
  • ReconRecon

    Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US ‘They rushed the process’: Vaccine maker Novavax's woes hamper global inoculation campaign ( Politico ) ( Reuters ) Novavax expresses fresh confidence in its vaccine ( Politico ) Biogen banks on government coverage to restart stalled Alzheimer's drug sales ( Reuters ) Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations ( STAT ) Cigna's p...
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    FDA issues proposed OTC hearing aid rule

    The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.   Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017 . The act directed FDA to create a report available f...
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    EMA shares lessons learned from biosimilars pilot

    The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the agency’s recently concluded biosimilar scientific advice pilot.   Also, EMA found that current regulatory guidelines, which assume that developers will take a stepwise approach to biosimilar development where clinical studies are condu...
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    FDA says IRB review still needed for IVD studies involving human specimens

    The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, "deidentified" human specimens still have to be approved by Institutional Review Boards (IRBs).   This pronouncement was made in an 18 October reminder letter to IVD manufacturers by William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within FDA’s Center for Devices and Radiological Health. ...
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    Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation

    Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient information materials are provided after holding a consultation into possible reforms.   TGA has been phasing in requirements for sponsors of implantable medical devices to provide patient information leaflets (PIL) and patient implant cards (PIC) since late 2018. The experience has triggered feedback from consumers, healthcare professionals, surgeons, hosp...
  • ReconRecon

    Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA proposes over-the-counter hearing aids for Americans ( Reuters ) ( FDA ) Pfizer-BioNTech’s vaccine is highly effective against hospitalization for those 12 to 18, a study shows. ( NYTimes ) J&J keeps vaccine sales outlook unchanged after third-quarter miss ( Reuters ) FDA to Allow ‘Mix and Match’ Approach for Covid Booster Shots ( NYTimes ) ( Reuters ) At...
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    EC updates Clinical Trial Regulation Q&As ahead of January go-live

    The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.   The revision clarifies that active pharmaceutical ingredients (APIs) used in investigational medical products do not have to comply with good manufacturing practices (GMPs) in the clinical trial application, describes the content of the protocol synopsis, and adds a new question o...
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    Cyltezo approved as interchangeable biosimilar with Humira

    An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).        Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulce...
  • ReconRecon

    Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA considering lowering recommended age for Pfizer/BioNTech COVID-19 boosters ( Reuters ) FDA delays decision on Moderna's COVID-19 vaccine for adolescents ( WSJ ) ( Reuters ) FDA declines to approve Revance's frown-line treatment ( Reuters ) ( Endpoints ) Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes ( Reuters ) ( Endpoints ) ...
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    FDA officials tout progress and achievements in advanced manufacturing

    The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...