RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 

  • 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...
  • Regulatory NewsRegulatory News

    Hahn says COVID-19 vaccines will be reviewed in ‘real time’

    At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami on Monday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine.   Pfizer also announced on Monday that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participan...
  • ReconRecon

    Recon: Pfizer, BioNTech begin pivotal COVID-19 vaccine trial; Drugmakers skip out on White House meeting

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers refuse to attend White House meeting after Trump issues executive orders on costs ( Politico ) ( Reuters ) Moderna, Pfizer start decisive COVID-19 vaccine trials, eye year-end launches ( Reuters ) ( NYTimes ) Pfizer-BioNTech begin late-stage study of lead COVID-19 vaccine candidate ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Pfizer shares rise afte...
  • Regulatory NewsRegulatory News

    Gene therapies: Industry asks for clarification on FDA’s sameness guidance

    Biotech companies and industry groups are raising questions about the US Food and Drug Administration’s (FDA) recent draft guidance on interpreting sameness of gene therapy products under its orphan drug regulations.   The draft guidance, issued for comment in January, explains how FDA intends to determine the sameness of two gene therapies intended for the same use or indication for the purposes of awarding orphan drug designation and exclusivity. (RELATED: FDA fina...
  • ReconRecon

    Recon: Moderna launches Phase 3 COVID-19 vaccine testing; AstraZeneca, Daiichi sign $6B deal for targeted cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump signs orders aimed at lowering drug prices in largely symbolic move ( Washington Post ) ( STAT ) ( NYTimes ) ( Reuters ) Meadows says White House is 'hopeful' it can announce new coronavirus therapies 'in the coming days' ( The Hill ) Gilead's second act in cell therapy gets its first approval ( BioPharmaDive ) ( Endpoints ) ( FDA ) Moderna gets further ...
  • ReconRecon

    Recon: EU looks to pay less than $40 per COVID-19 vaccine; Taro to pay upwards of $200M to settle price-fixing suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump will sign executive orders on lowering drug prices on Friday: White House ( Reuters ) Trump drops plan to eliminate government drug rebates ( Politico ) US Clears Way for Drugmakers to Share COVID Antibody Capacity ( Reuters ) Taro Pharmaceuticals to pay more than $200 million to settle US price-fixing probe ( Reuters ) ( DOJ ) AstraZeneca's lung diseas...
  • Regulatory NewsRegulatory News

    PDUFA VII: FDA, industry preview their reauthorization wish lists

    At its first public meeting in the runup to the reauthorization of the Prescription Drug User Fee Act, the US Food and Drug Administration (FDA), industry and other stakeholders on Thursday shed light on their goals for what will be the agency’s seventh PDUFA program.   The meeting, held fully virtually for the first time due to the COVID-19 pandemic, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s new ...