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

  • 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)...
  • 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

    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...
  • Regulatory NewsRegulatory News

    FDA offers new Q&A on biosimilars and interchangeable products

    In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars.   When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.   In the first of four questions and answers in the draft guidance, FDA explains how i...
  • ReconRecon

    Recon: UK asks MHRA to review Pfizer COVID vaccine; Novartis signs deal for Mesoblast cell therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer is first to apply for US emergency use for COVID-19 vaccine ( Reuters ) ( STAT ) 'We cannot rest': Despite promising Covid-19 vaccine results, trials must continue ( NBC ) Five US agencies have started telling employees they could get Covid vaccine shots in as little as 8 weeks ( CNBC ) Trump will announce on Friday rules to lower US drug prices ( Reute...
  • Regulatory NewsRegulatory News

    FDA, Industry set priorities for BsUFA III

    At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US Food and Drug Administration (FDA) and industry shared their wish lists for the third iteration of the agency’s biosimilars review program.   While FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeab...
  • Regulatory NewsRegulatory News

    FDA issues 34 new and revised product-specific guidances

    In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances released by the agency to 1,974.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a refe...
  • Regulatory NewsRegulatory News

    EMA revises remote pharmacovigilance inspections guide

    The European Medicines Agency (EMA) has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic.   The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis.   In the revised document, EMA has replaced the term “distant/virtual” with “remote” and has expande...
  • ReconRecon

    Recon: Judge approves $8.3B Purdue settlement; Congo declares end of Ebola outbreak

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer To Seek FDA OK For COVID-19 Vaccine 'Within Days’ ( NPR ) ( NYTimes ) ( STAT ) ( Reuters ) ( CNN ) ( Press ) FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization ( CNBC ) Pfizer says analysis shows 3.8% of participants experienced fatigue ( Reuters ) Americans Are More Willing to Take a Coronavi...
  • Regulatory NewsRegulatory News

    Hahn addresses EUAs, transition to approvals in conversation with RAPS members

    Real-world data has proven useful in demonstrating the performance of COVID-19 diagnostics, but has not always lined up with the data submitted to support the emergency use authorizations (EUA) of those product. That was one message Stephen Hahn, MD, US Food and Drug Administration (FDA) commissioner brought to RAPS members during a conference call on Tuesday.   “The real-world application of these tests differs from the science and data that are used for us to make th...
  • ReconRecon

    Recon: FDA delays decision on BMS’ liso-cel therapy; Amazon launches online pharmacy service

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA delays decision on Bristol Myers cancer therapy due to COVID-19 travel curbs ( Reuters ) ( Endpoints ) ( Press ) FDA rejects Alkermes schizophrenia drug, citing manufacturing concerns ( BioPharmaDive ) ( Endpoints ) Amazon launches online pharmacy in new contest with drug retail ( Reuters ) ( STAT ) US hospitals to restrict Lilly COVID-19 antibody treatmen...