• Regulatory NewsRegulatory News

    Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized

    In a tumultuous year coinciding with the agency’s five-year user fee reauthorization cycle, US Food and Drug Administration (FDA) Commissioner Robert Califf discussed his priorities for the agency and what happens if its user fee programs are not reauthorized before the current programs expire.   Califf made the remarks and shared his three- to five-year vision for the agency during a virtual meeting with the Alliance for a Stronger FDA on 12 July.   User fees and a...
  • RoundupsRoundups

    Asia-Pacific Roundup: India releases a trio of IVD guidances for consultation

    India’s Central Drugs Standard Control Organization (CDSCO) has released three draft guidance documents that will reshape how manufacturers of in vitro diagnostics (IVDs) approach performance evaluation, postmarket surveillance and stability studies.   The draft texts, which are open for comment, build on the Medical Devices Rules (MDR), 2017, which came into force at the start of 2018 and regulate the manufacture, import, sale and distribution of notified medical devi...
  • ReconRecon

    Recon: CDC says pandemic drove US deaths from antibiotic resistant superbugs; Biden officials mulling expanding second booster to all adults

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US deaths from antibiotic resistant 'superbugs' rose 15% in 2020 ( Reuters ) ( Washington Post ) Biden officials push to offer second booster shots to all adults ( Washington Post ) ( Bloomberg ) White House to prioritize boosters, testing for Omicron BA.5 subvariant ( Reuters ) 'Approvability has been put to bed': Aldeyra says eye drop clears three dry eye si...
  • Regulatory NewsRegulatory News

    EMA: Pilot bringing ex-EU regulators to COVID product meetings was a success

    Involving non-EU regulatory authorities in the assessment of COVID-19 vaccines and therapies helped regulators accelerate and align on decisions, according to a new report from the European Medicines Agency (EMA).   EMA made the comments in a review of the OPEN (Opening our Procedures at EMA to Non-EU authorities) initiative also reporting that it “had enhanced communication channels and facilitated discussions and exchanges.”   The OPEN programme – which debuted...
  • Regulatory NewsRegulatory News

    Proposed legislation takes aim at prescription drug advertising

    New legislation recently introduced in the House of Representatives would direct the US Food and Drug Administration (FDA) to finalize a long-dormant final rule requiring pharmaceutical manufacturers to include a statement on drug labeling warning of a drug’s risks and side effects “in a clear, conspicuous, and neutral manner.”   The Banning Misleading Drugs Act , introduced by Rep. Abigail Spanberger (D-VA) on 5 July, would require FDA to “finalize a 15-year old prop...
  • Regulatory NewsRegulatory News

    Personalized medicine growth hindered by outmoded drug development paradigm

    There has been explosive growth in the number of applications and approvals for personalized medicines, yet the current drug development paradigm is not optimizing the development of these treatments, asserted Kenneth Getz, the executive director of the Tufts Center for the Study of Drug Development (CSDD).   Getz told Regulatory Focus in a 7 July interview that over the past 20 years, there has been unprecedented growth in the number of personalized development ther...
  • ReconRecon

    Recon: FDA to review first OTC birth control pill; EU recommends second COVID booster for over-60s

    In Focus: US Drugmaker seeks FDA approval of over-the-counter birth control pill ( STAT ) ( Reuters ) ( Washington Post ) FDA grants full approval to Pfizer COVID vaccine for ages 12-15 ( Reuters ) Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half ( The Pink Sheet ) In wake of unexpected patient deaths, MacroGenics closes down PhII cancer trial ( Endpoints ) Drug Pricing Plan Faces Industry Gripes as Senate Reconvenes ( Bloombe...
  • Feature ArticlesFeature Articles

    June’s Regulatory Focus: Nutrition in health and disease management

    Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS announces board slate for term beginning in 2023

    The RAPS nominating committee has selected the slate of new members set to join the RAPS Board of Directors for its next term, beginning 1 January 2023. The committee carefully reviewed submitted nominations materials and made its selections based on professional experience, substantive involvement with RAPS and a clearly articulated vision for expanding the global reach of the organization and advancing the regulatory profession. The following members are set to j...
  • Regulatory NewsRegulatory News

    Stakeholders seek tweaks to FDA’s voluntary improvement program guidance

    The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know more about how manufacturers can benefit from participating as well as how the program fits into existing regulatory programs.   FDA’s participation in the VIP means device manufacturers can be assessed by third party appraisers that provi...
  • This Week at FDAThis Week at FDA

    This Week at FDA: USPTO, FDA align on drug competition, Paxlovid from your pharmacist, and more

    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, we learned that FDA is looking to hire a media-savvy physician to direct its communication strategy. The agency also authorized state-licensed physicians to prescribe Pfizer’s COVID-19 antiviral drug. Plus, we read that FDA and the US Patent and Trademark Office (USPTO) are pl...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    What it’s like to present a poster at Euro Convergence, with Raquel Carnero

    Euro Convergence, RAPS’ annual gathering of medical device, in vitro diagnostic (IVD) and pharmaceutical regulatory professionals, returned in person to Amsterdam on 11-13 May 2022 . More than 500 participants, including 120 industry expert speakers from more than 30 health authorities and notified bodies, made it an event to remember in Amsterdam after two years of virtual conferences. Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raque...