• Regulatory NewsRegulatory News

    This Week at FDA: New OTC hearing aid rule, Bavarian Nordic upset over Jynneos EUA

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the FDA released a long-awaited over-the-counter hearing aid rule, we learned that the Biden Administration got some pushback from Bavarian Nordic for allowing smaller doses of their monkeypox vaccine and the UK became the first country to approve a bivalent COVID-19 vaccine....
  • Regulatory NewsRegulatory News

    Study: Most accelerated approval indications don’t add high therapeutic value

    Less than half of the new drug indications approved through the accelerated approval pathway in the United States and the conditional marketing authorization pathway in Europe offered “high added therapeutic value,” according to an analysis of approvals from 2007 through 2021. A lower proportion of cancer indications were rated as having high therapeutic value, compared with non-cancer indications.   “Our study findings that many drugs granted accelerated approval or c...
  • Regulatory NewsRegulatory News

    OIG reprimands NIH for not enforcing trial transparency requirements

    The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) says the National Institutes of Health (NIH) has failed to hold NIH-funded researchers accountable for publishing clinical trial data. The watchdog agency has made several recommendations to ensure better transparency in the future.   The OIG published a report on 12 August criticizing the NIH for not fully enforcing federal reporting requirements for intramural and extramural stud...
  • RoundupsRoundups

    Euro Roundup: UK committee advises a mix of COVID boosters for autumn

    The UK Joint Committee on Vaccination and Immunisation (JCVI) has recommended a mix of COVID-19 vaccines based on the original wild-type SARS-CoV-2 virus as well as Moderna’s bivalent COVID-19 vaccine that targets both the original virus and the B.1 Omicron variant for its autumn booster program.   JCVI advised the UK government to adopt Pfizer’s Comirnaty and Moderna’s Spikevax for the autumn booster program in addition to Moderna’s bivalent COVID-19 vaccine for adult...
  • Regulatory NewsRegulatory News

    FDA updates 19-year-old replacement reagent policy for IVDs

    The US Food and Drug Administration (FDA) on Tuesday finalized its guidance explaining its policies for replacement reagents and instrument families for in vitro diagnostics (IVDs), replacing an earlier policy issued in 2003.   The guidance outlines FDA’s policy to allow IVD makers to avoid having to submit new 510(k)s for certain changes to their tests and supersedes the 2003 version. FDA issued a draft version of the guidance for comment in 2017. (RELATED: New dr...
  • ReconRecon

    Recon: FDA approves Bluebird’s beta-thalassemia gene therapy; WHO recommends Valneva COVID vaccine

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Bluebird's $2.8 million gene therapy becomes most expensive drug after U.S. approval ( Reuters ) ( Endpoints ) ( STAT ) ( FDA ) FDA says faulty Philips device reports accelerating as CEO departs ( Reuters 1 , 2 ) HHS says it plans to extend Covid-19 public health emergency ( Politico ) White House: Updated boosters for adults, teens expected in a few weeks ( The H...
  • Regulatory NewsRegulatory News

    FDA drafts guidance to improve hydrogen peroxide-based contact lens care product labeling

    The US Food and Drug Administration has developed draft guidance for manufacturers of hydrogen peroxide-based contact lens care products (HPCP) to consider when labeling their solutions in response to a number of adverse events, including cases where consumers have lost their eyesight.   On 17 August, FDA published a draft guidance titled, “ Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissio...
  • Regulatory NewsRegulatory News

    Study: Public funding was instrumental to early development of COVID therapeutics, vaccines

    In the first year and a half of the COVID-19 pandemic, public funding played a major role in the development of COVID-19 therapeutics and vaccines, according to recent research published in JAMA Network Open .   Aris Angelis, PhD, of the department of health services research and policy at the London School of Hygiene and Tropical Medicine in London, and colleagues examined 1,977 clinical Phase 1-3 trials of COVID-19 vaccines and therapeutics that launched between Jan...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS honors 11 distinguished professionals and one advocacy group with 2022 awards

    The Regulatory Affairs Professionals Society (RAPS) recognizes 11 distinguished professionals and one patient-advocacy organization with awards for their support of the regulatory profession and work toward advancing public health.  RAPS’ Founder’s Award, Community Leadership Award and Patient-Centered Health Award are presented annually during RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. RAPS Conve...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    RAPS announces the 2022 Fellows Program recipients

    The Regulatory Affairs Professionals Society (RAPS) has named 10 exceptional senior regulatory professionals to the distinguished ranks of the RAPS Fellows Program. The 2022 RAPS Fellows are:   Kimberly Belsky, FRAPS, MS, Executive Director, Regulatory Policy & Intelligence and AdPromo, Mallinckrodt Pharmaceuticals  Paul C. Brooks, FRAPS, Retired  Monique J. Carter, FRAPS, MS, RAC-US, Senior Director and Global Regulatory Lead, Pfizer  Niedre M. Heckman, F...
  • Regulatory NewsRegulatory News

    FDA warns Emergent BioSolutions over GMP violations at Camden facility

    The US Food and Drug Administration (FDA) issued a warning letter to Emergent BioSolutions subsidiary Cangene BioPharma outlining violations of current good manufacturing practice (CGMP) regulations found during a February 2022 inspection of their Camden manufacturing facility in Baltimore.   In the warning letter, FDA said Emergent did not appropriately clean and sanitize equipment at the facility “to prevent malfunctions or contamination that would alter the safety, ...
  • Regulatory NewsRegulatory News

    FDA creates new category of OTC hearing aids, issues PSAP guidance

    After pressure from the Biden Administration, the US Food and Drug Administration finalized a much-anticipated rule that allows certain air conduction hearing aids to be available over-the-counter (OTC) without the need for hearing exams or fittings. At the same time, the agency also published a final guidance on personal sound amplification products that clarifies how they are different from hearing aids.   On 16 August, FDA announced a final rule that removes signi...