• ReconRecon

    Recon: Pfizer in talks to acquire Seagen; EMA backs approval for 8 new drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer in Talks to Acquire Seagen in Deal Likely Valued at More Than $30 Billion ( WSJ ) ( BioPharma Dive ) ( Endpoints ) Pfizer’s Paxlovid to Face FDA Advisory Panel Meeting on March 16 ( Bloomberg ) ( Endpoints ) After ACIP Gambit, Pfizer, GSK Take RSV Vaccines To US FDA Adcomm ( Pink Sheet ) Pfizer spinout SpringWorks gets FDA priority review for lead drug ...
  • Regulatory NewsRegulatory News

    Legal expert: FDA inspections will start looking at DSCSA compliance

    Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes full effect this November, the US Food and Drug Administration (FDA) will begin inspecting firms to verify their compliance, asserted Howard Sklamberg, a partner at Arnold & Porter.   He outlined what FDA will be looking for in inspections at a 22 February webinar sponsored by the Food and D...
  • This Week at FDAThis Week at FDA

    This Week at FDA: FDA names new Office of Compliance, CVM directors

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that FDA has filled two leadership roles at the agency, and that it will host an upcoming patient-focused drug development (PFDD) meeting focused on long COVID. It also announced the authorization of the first at-home test for COVID-19 and influenza.   On Friday...
  • ReconRecon

    Recon: FDA approves Sanofi’s bleeding disorder drug; Sen. Warren calls for scrutiny of Merck’s Keytruda patents

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA approves Sanofi’s bleeding disorder therapy ( Reuters ) ( Endpoints ) Moderna’s combination skin cancer therapy receives FDA’s breakthrough tag ( Reuters ) Facing Roche threat, Regeneron eyes June approval for high-dose version of Eylea ( Fierce ) Alnylam gets an adcomm for Onpattro treatment in ATTR amyloidosis ( Endpoints ) FDA to take another look...
  • Regulatory NewsRegulatory News

    Industry groups call for changes in ICH M11 guideline on harmonized protocols

    In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11 guidance establishing a harmonized template for clinical trial protocols. The groups said the document should be revised to broaden the definition of a protocol, recommended that the use of estimands be justified in the protocol and include more examples of real-world data (RWD).   The guidance also inc...
  • Regulatory NewsRegulatory News

    Transparency, transition period addressed in new EMA Q&A guidance on CTR implementation

    The European Medicines Agency (EMA) has issued a guidance in a question-and-answer format to assist sponsors in navigating the Clinical Trials Regulation (CTR) and the new clinical trials information system (CTIS) portal. Use of the CTIS became mandatory on 31 January.   The Q&A was developed by EMA’s Query Management Working Group (QMWG) to clarify some areas of ambiguity raised by stakeholders, which included the Association of Clinical Research Organizations (ACRO),...
  • ReconRecon

    Recon: FDA grants priority review to Pfizer’s RSV vaccine; Merck’s COVID pill falls short in preventing infection

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer’s maternal RSV vaccine filing gets priority review, setting up showdown with AstraZeneca, Sanofi ( Fierce ) ( BioPharma Reporter ) ( BioSpace ) Icosavax Granted FDA Fast Track Designation for IVX-A12 ( BioSpace ) ( Yahoo Finance ) ( Precision Vaccinations ) Akebia’s Appeal for Anemia in CKD Drug Delayed Again ( BioSpace ) Pharmalittle: Cystic fibrosis p...
  • Regulatory NewsRegulatory News

    GAO calls for better FDA oversight of IRBs

    The US Food and Drug Administration (FDA) needs to do a better job of tracking and monitoring the activities of institutional review boards (IRBs); not doing so compromises the safety of research participants enrolled in clinical trials, according to a new report from the Government Accountability Office (GAO). These findings also apply to the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP).   The 16 February report describes...
  • ReconRecon

    Recon: FDA approves Apellis’ eye disorder drug Syfovre; Pfizer pulls participants from Lyme disease trial over GCP issues

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves first treatment for leading cause of blindness in older people ( STAT ) ( BioSpace ) ( Endpoints ) ( Fierce ) U.S. FDA approves Travere Therapeutics kidney disorder drug ( Reuters ) ( STAT ) ( Endpoints ) ( BioSpace ) Astellas has menopause accelerated approval ambition thwarted by FDA at last minute ( Fierce ) FDA accepts Iveric Bio's NDA, grants...
  • Regulatory NewsRegulatory News

    Stakeholders want clarity from FDA on circumstances for delaying or limiting inspections

    The Advanced Medical Technology Association (AdvaMed) and ophthalmology product maker Alcon urged the US Food and Drug Administration (FDA) to allow manufacturers more latitude in being able to delay or limit inspections before deeming products adulterated. They also urged FDA to clarify what constitutes a reasonable explanation for delaying, denying or refusing an inspection.   These comments were in response to FDA’s revised draft guidance issued in December 2022 on ...
  • Regulatory NewsRegulatory News

    OPQ touts progress on quality management maturity, KASA in annual report

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) reported that progress has been made over the past year in advancing its quality management maturity initiative and in its quality assessment review process in its 2022 annual report.   The report also describes progress made in other areas under OPQ’s remit. The office’s previous two reports focused largely on its COVID-19 response. (RELATED:  FDA’s OPQ reports on drug quality efforts ...
  • ReconRecon

    Recon: FDA advisors back OTC switch for naloxone; Grifols to lay off 2,000 US staff

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Advisors Endorse Moving Naloxone Over the Counter ( MedPage Today ) ( Reuters ) ( Endpoints ) ( Pink Sheet ) FDA to review Galera’s drug for radiotherapy complication, biotech immediately seeks $30M ( Endpoints ) Pfizer gives interim update on PARP inhibitor combo treatment, earns priority review at FDA ( Endpoints ) Thousands of gene and cell therapies ar...