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  • Regulatory NewsRegulatory News

    PDUFA VII: FDA and industry set priorities in first round of negotiations

    After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.   The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government ...
  • ReconRecon

    Recon: Novartis buys Vedere Bio for $150M upfront; Gilead reports $873M in remdesivir sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A P value of 0.38? NEJM results raise new questions for Eli Lilly's vaunted Covid antibody ( Endpoints ) ( NEJM ) Regeneron Covid-19 Therapy Reduces Viral Load, Need for Care ( Bloomberg ) ( Endpoints ) ( NBC ) Antibody drugs seem to work. But the virus is moving faster than we can make them ( STAT ) Moderna on track to report late-stage COVID-19 vaccine data ...
  • ReconRecon

    Recon: Sanofi, GSK to supply 200M vaccine doses to COVAX scheme; US strikes deal for Lilly’s COVID antibody drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO All but Rules Out Vaccine Before Election Day ( NYTimes ) ( FT ) US strikes deal with Lilly for potential COVID-19 antibody drug ( Reuters ) ( Endpoints ) ( Press ) Lawmakers release trove of Purdue documents detailing Sackler family’s involvement in opioid sales ( STAT ) I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe an...
  • Regulatory NewsRegulatory News

    MDUFA V: Industry wants fine tuning while FDA seeks expansion

    The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.   The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.   During the meeting, FDA officials...
  • Regulatory NewsRegulatory News

    FDA delays enforcement of some DSCSA provisions by three years

    The US Food and Drug Administration (FDA) last week announced it will again delay enforcement of a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesalers to verify saleable returned drugs they intend to further distribute.   “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(...
  • ReconRecon

    Recon: FDA delays decision on Spectrum drug due to COVID travel restrictions; Bayer to buy AskBio for up to $4B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA delays decision on Spectrum Pharma's drug candidate due to travel curbs ( Reuters ) ( Endpoints ) Two Companies Restart Virus Trials in U.S. After Safety Pauses ( NYTimes ) ( FT ) South Korea pharma Celltrion's COVID test gets US emergency use authorisation ( Reuters ) U.S. disease expert Fauci says vaccine verdict due by early December ( Reuters ) Senate...
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    FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

    With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...
  • ReconRecon

    Recon: Moderna completes enrollment in Phase 3 COVID vaccine study; Dr Reddy’s hit by cyberattack

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US An angry Azar floats plans to oust FDA’s Hahn ( Politico ) Moderna completes enrollment in large COVID-19 vaccine study ( Reuters ) Roche, Atea team up on potential COVID-19 pill ( Reuters ) US likely to have enough COVID-19 vaccines for all vulnerable Americans by year end: official ( Reuters ) Why the US doesn’t have an at-home coronavirus test yet ( Politi...
  • Regulatory NewsRegulatory News

    FDA approves fewer generics in FY2020, ending record streak

    After four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals, the US Food and Drug Administration (FDA) has broken its streak, approving 22% fewer generic drugs in FY2020 than it did in FY2019.   In FY2020, FDA approved a total of 909 ANDAs, 737 full approvals and 172 tentative approvals, compared to a record 1,171 ANDAs in FY2019. Complete responses also declined to 2,010 compared to 2,310 in FY2019. (RELATED: Another reco...
  • ReconRecon

    Recon: Purdue pleads guilty to criminal charges over opioid sales; EU signs deal for J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Purdue Pharma Pleads Guilty to Criminal Charges for Opioid Sales ( NYTimes ) AstraZeneca close to restarting Covid-19 vaccine trial in US ( Politico ) ( Reuters ) Covid-19 vaccine researchers left in the dark as trials remain on hold ( NBC ) Lilly hires external adviser for COVID-19 drug plant problems ( Reuters ) ( Bloomberg ) States prepare for their own va...
  • Regulatory NewsRegulatory News

    Eudamed: EC posts info on actor registration module

    With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.   The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to ...
  • ReconRecon

    Recon: GAO to probe interference at CDC, FDA; Moderna expects interim COVID vaccine results in November

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Government watchdog will probe Trump officials’ interference at CDC, FDA ( Politico ) US FDA meeting on COVID-19 vaccines to discuss criteria for emergency nod ( Reuters ) California to independently review FDA-approved coronavirus vaccines ( Axios ) ( Reuters ) Moderna CEO Expects Covid-19 Vaccine Interim Results in November ( WSJ ) ( Reuters ) Kodak to Push...