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  • Regulatory NewsRegulatory News

    Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

    President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.   Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must pro...
  • ReconRecon

    Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA grants expedited review to Biogen's Alzheimer's drug ( Reuters ) ( Bloomberg ) ( STAT ) Trump Signs Executive Order to Boost US Production of Essential Medicine ( WSJ ) ( STAT ) Teva CEO Has Doubts About Making Generic-Drug Ingredients in the U.S. ( Barron’s ) Moderna Backtracks to Open Covid Vaccine Trial to Those With HIV ( Bloomberg ) Pfizer to make Gi...
  • Regulatory NewsRegulatory News

    FDA: Most postmarketing requirements, commitments progressing on schedule

    In its latest annual report on drugmakers’ performance in conducting postmarket requirement (PRMs) and postmarketing commitments (PMCs), the US Food and Drug Administration (FDA) says that most studies are progressing on schedule.   Background   A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct, but is not ...
  • ReconRecon

    Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Plans Order Seeking to Return Drug Production to US ( Bloomberg ) ( Politico ) ( STAT ) ( Endpoints ) ( Reuters ) FDA commissioner: No matter what, only a safe, effective vaccine will get our approval ( Washington Post ) FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020 ( NPR ) Trump says coronavirus vaccine possible before Nov. 3 ( Reuters...
  • Regulatory NewsRegulatory News

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
  • ReconRecon

    Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate ( Reuters ) ( FT ) US government begins two trials testing Eli Lilly’s coronavirus antibody drug ( CNBC ) Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma ( WSJ ) ( Reuters ) Novavax’s Covid-19 vaccine shows promising immune response, early data sho...
  • Regulatory NewsRegulatory News

    Global regulators agree on endpoints for COVID-19 therapeutics

    Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat coronavirus disease (COVID-19).   In a teleconference on 20 July 2020 co-chaired by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), ICMRA members reviewed potential endpoint...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • ReconRecon

    Recon: US to pay $2.1B for Sanofi, GSK COVID-19 vaccines; AbbVie, Gilead report Q2 results

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $2.1B to Sanofi, GSK, in COVID-19 vaccine deal ( Reuters ) ( Politico ) ( NYTimes ) ( Press ) Trump planning for US rollout of coronavirus vaccine falling short, officials warn ( Reuters ) Large US COVID-19 vaccine trials will exclude pregnant women for now ( Reuters ) Merck plans large trials of antiviral COVID-19 drug in September ( Reuters ) Chin...
  • ReconRecon

    Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half profit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers Race to Build Covid-19 Vaccine Supply Chains ( WSJ ) FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks ( CNN ) FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma ( WSJ ) J&J starts human study of COVID-19 vaccine after promising monkey data ( Reuters ) ( FT ) ( NYTimes ) Inovio vaccine ...
  • Regulatory NewsRegulatory News

    FDA revises draft PLLR guidance

    The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance providing recommendations on the content and format of labeling required under the pregnancy and lactation labeling rule (PLLR).   The draft guidance was first issued alongside the final PLLR in 2014, with the rule itself taking effect in June 2015. The PLLR revised labeling requirements under the 2006 physician labeling rule, to “provide a framework for clearly communicating information ...
  • ReconRecon

    Recon: Moderna eyes $50-60 price for COVID-19 vaccine; UK signs deal for Sanofi, GSK coronavirus vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna pitches virus vaccine at about $50-$60 per course ( Financial Times ) ( STAT ) Moderna Vaccine Test in Monkeys Shows Promise ( NYTimes ) Most voters say they'd rather wait for an effective coronavirus vaccine ( Politico ) Public Health Experts Fear a Hasty FDA Signoff on Vaccine ( KHN ) ‘Nobody Likes Me,’ Trump Complains, Renewing Defense of Dubious S...