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  • Regulatory NewsRegulatory News

    CDC advisory committee ponders COVID vaccine priorities

    Health care workers would be among the first to receive vaccines against COVID-19 in a timeline presented to the Centers for Disease Control and Prevention’s (CDC’s) vaccines advisory committee. The proposed scheme would have essential workers next in line for vaccination, ahead of those with serious medical comorbidities and most of the elderly. In a 23 November meeting, CDC’s Advisory Committee on Immunization Practices (ACIP) heard presentations and advice from a work...
  • Regulatory NewsRegulatory News

    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs)...
  • Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Abstract Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information,...
  • RoundupsRoundups

    Asia-Pacific Roundup: India clarifies ‘Make in India’ medical device order

    Guidance from the Indian Department of Pharmaceuticals clarifies how companies can take advantage of an order intended to encourage the use of local suppliers of medical devices. The order , published in September, created two groups of local suppliers that will be eligible to bid on many contract, Class I and Class II.  Class I suppliers will win the full quantity of any contract for which they are the lowest bidder, while Class II or non-local suppliers who submit the...
  • ReconRecon

    Recon: FDA approves Alnylam’s Oxlumo for PH1; EU secures 160M doses of Moderna vaccine

    In Focus: US Alnylam wins US approval for its third rare disease drug ( BioPharmaDive ) ( FDA ) Vaccinating a nation: can Biden manage America’s biggest health project? ( FT ) A Revamped Strategic National Stockpile Still Can't Match The Pandemic's Latest Surge ( NPR ) Amgen cuts Cytokinetics loose after heart drug disappointment ( BioPharmaDive ) A top Democrat on the House antitrust panel sets sights on Big Pharma after wrapping up tech probe ( CNBC ) PhRMA s...
  • Regulatory NewsRegulatory News

    WHO proposes update of GMPs for investigational products

    The World Health Organization is revising its guidance to industry on good manufacturing practices for investigational drug products, including new recommendations for quality risk management. The draft working document , which was released in November 2020, is open for public comment until 6 January 2021. The draft is expected to be revised and go through a second round of public comment before being presented to the WHO’s Expert Committee on Specifications for Pharmac...
  • Regulatory NewsRegulatory News

    FDA launches online orphan submissions portal

    The US Food and Drug Administration (FDA) on Monday launched a new cloud-based submission portal for orphan drug designation requests, shifting away from the current paper and CD-based submission process. The new portal, first announced in January, is part of the agency’s orphan drug technology modernization effort and fits in with its broader technology modernization plans. The shift to electronic submissions follows a decade of increasing orphan drug designation reques...
  • ReconRecon

    Recon: Merck to buy OncoImmune for $425M; FDA approves first drug for Progeria

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca to seek FDA authorization for vaccine based on foreign trial data ( Politico ) FDA approves first drug for rare disease that causes premature aging in children ( Boston Globe ) ( FDA ) FDA approves Xofluza for post-expousre prevention ( FDA ) US infectious disease group backs Gilead's remdesivir for COVID-19 treatment ( Reuters ) Trump unveils pla...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Three therapeutics have received emergency use authorizations (EUAs) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to updated...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. The Herculean effort means that a fast-tracked vaccine could come to market anywhere from the  end of 2020  to the middle of  2021 .   To date, just two coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of th...
  • Regulatory NewsRegulatory News

    Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December

    With favorable results from a completed Phase 3 clinical trial of their jointly developed vaccine against COVID-19, Pfizer and BioNTech have submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) according to Pfizer CEO Albert Bourla. The agency has set a 10 December date for the Vaccines and Related Biological Products Advisory Committee to review the EUA request. The meeting will be broadcast live on Facebook, Twitter, ...