• Regulatory NewsRegulatory News

    HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures

    US Department of Health and Human Services (HHS) officials are proposing to repeal two rules issued in the final days of the Trump Administration, calling them a “burden” and “inconsistent with the policies and goals of the current Administration.”   In a proposed rule issued on 20 October 2021, HHS outlined plans to roll back a final rule on guidance document procedures and another on civil administrative enforcement and adjudication procedures. The two final rules st...
  • RoundupsRoundups

    Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions

    The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking feedback on its preliminary position.   CHMP officials adopted the opinion on IMI PREFER, an Innovative Medicines Initiative-funded “framework with points to consider when selecting methods for industry, regulators and health technology a...
  • ReconRecon

    Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Moderna, J&J Covid-19 boosters, allows mix-and-match shots ( Politico ) ( Reuters ) ( FDA ) A C.D.C. panel is meeting for debate on boosters and the ‘mix-and-match’ strategy. ( NYTimes ) A 30-Year Campaign to Control Drug Prices Faces Yet Another Failure ( NYTimes ) Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large ...
  • Regulatory NewsRegulatory News

    FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires

    Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administration (FDA) to issue three warning letters for good manufacturing practice (GMP) violations to an over the counter drug manufacturer, a finished drug manufacturer and an API manufacturer in the US.   The recipients of the warning letters, w...
  • Regulatory NewsRegulatory News

    FDA okays Moderna, J&J, 'mix and match' boosters

    The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizing heterologous booster doses for all populations eligible for boosters under today's expansion of the emergency use authorizations for COVID-19 vaccines.   A booster is recommended for all recipients of the one-dose Janssen vaccine, an...
  • RoundupsRoundups

    FDA Approvals Roundup: Tyrvaya, Zimhi, Biktarvy

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tyrvaya nasal spray okayed for dry eye disease Oyster Point’s Tyrvaya (varenicline solution nasal spray) has been approved for treating dry eye disease.   Approval for Tyrvaya, a highly selective cholinergic agonist, was based on efficacy findings from the randomized, multicenter, double-masked, vehicle-controlled ONSET-1 , ONSET-2 , and...
  • 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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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. ...