• Regulatory NewsRegulatory News

    This Week at FDA: User fee update, Califf nomination, and more

    Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transmitted three of FDA’s user fee packages to Congress – with one notable exception – and, as we reported on Thursday, FDA is one step closer to having a permanent commissioner.   Earlier this week, we read that FDA and the medical device...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Dozens of vaccines now have been authorized or approved around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that a...
  • Regulatory NewsRegulatory News

    WHO charts path to convergence on cell and gene therapies

    The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.   It proposes that autologous human cell and tissue (HCT) products for medical use be accorded a lower level of regulatory control than advanced therapy medical products (ATMPs), such as cell and gene therapies or tissue engineering products.  ...
  • Regulatory NewsRegulatory News

    Senate committee advances Califf’s nomination as FDA commissioner

    The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).   The vote split largely along party lines, with six Republicans joining Sens. Bernie Sanders (I-VT) and Maggie Hassan (D-NH) in voting against moving the nomination forward. Both Sanders and Hassan , along with Sens. Joe Manchin (D-WV) and Ed Markey (D...
  • ReconRecon

    Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Panel OKs Califf Nomination for FDA Chief ( NYT ) ( Inside Health Policy ) US Supreme Court blocks Biden vaccine-or-test policy for large businesses ( Reuters ) ( STAT ) GSK, Vir seek US approval for COVID-19 antibody therapy as shot in arm ( Reuters ) FDA concerns at contractor Catalent site spurred on shortages of Novo Nordisk's semaglutide — report (...
  • Regulatory NewsRegulatory News

    Stakeholders seek clarity on FDA cell and gene therapy draft guidance

    Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell and gene therapies could combine them in a single “umbrella” trial.   The draft guidance, released in September 2021, outlined FDA’s proposed thinking for how this process would work. For cell and gene therapies intended to treat a single disease, sponsors would typically ...
  • RoundupsRoundups

    Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback

    The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.   Companies working with active substances, raw materials, starting materials or excipients that are the subject of a European Pharmacopoeia monograph can request a CEP from EDQM and include the text in their applications instead of cert...
  • Regulatory NewsRegulatory News

    Industry seeks delay for reporting manufacturing volume data

    Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up the necessary systems to comply with the manufacturing volume reporting provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to meet the February deadline set by the US Food and Drug Administration (FDA).   The Section 3112 of the CARES Act established new reporting requirements for manufacturers of finished dosage forms, API suppliers, over-t...
  • Regulatory NewsRegulatory News

    European Commission creates rules for allocating clinical trial safety oversight

    The European Commission has published an implementing regulation that details the process for picking a member state to assess information on suspected unexpected serious adverse reactions and describes their role in screening for safety signals in clinical trials.   European law requires clinical trial sponsors to report suspected unexpected serious adverse reactions to investigational medicinal products, as well as annual safety reports, to the European Medicines Age...
  • RoundupsRoundups

    FDA Approvals Roundup: Quviviq, Recorlev, Rexulti

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Quviviq nabs go-ahead for insomnia in adults Idorsia’s Quviviq ( daridorexant; tablets ) has been approved for treating adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance, pending controlled substance scheduling.   The approval was based on efficacy findings in two studies ( Study 1 and Study 2 )...
  • Regulatory NewsRegulatory News

    Chinese firm warned for making OTC eye drops without microbiological safeguards

    The US Food and Drug Administration (FDA) warned Chinese drugmaker Hubei Kangzheng for having inadequate microbiological controls to prevent contamination of its over-the-counter (OTC) eye drops. These violations partly stem from the firm’s misguided notion that the eye drops are non-sterile drugs, thus not to more stringent microbiological controls.   The warning letter was issued on 23 November 2021 and posted to FDA’s website on 11 January. It follows a nine-day ins...
  • ReconRecon

    Recon: CMS to restrict coverage of Aduhelm to only clinical trials; FDA warns of dental issues with buprenorphine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Criticized by Senators, US Health Officials Defend Omicron Response ( NYTimes ) ( Endpoints ) Omnicron will infect ‘just about everybody,’ Fauci says ( Washington Post ) FDA flags risk of dental issues from use of opioid addiction drug buprenorphine ( Reuters ) ( FDA ) CMS to restrict coverage of Biogen’s controversial Alzheimer’s drug to only clinical trials ...