• Regulatory NewsRegulatory News

    FDA extends comment period on ICH Q12 guidance

    The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.   The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).   FDA announced in a pre-publication notice in the 8 Septembe...
  • Regulatory NewsRegulatory News

    FDA says Turkish OTC maker’s testing program earns failing grades

    The US Food and Drug Administration (FDA) criticized a Turkish manufacturer of over-the-counter drugs for failing to test incoming ingredients and to test products before releasing them to the market in a recent warning letter . The company was also warned for its lax approach to stability testing.   The 13 May letter to Istanbul-based Gulsah Uretim Kozmetik Sanayi Anonim Sirketi follows up on FDA’s review of a 23 April response to request for records. The firm is the...
  • ReconRecon

    Recon: Sanofi acquires Kadmon for $1.9B; COVAX cuts 2021 delivery target by 1.425B doses

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna turns to biotech startup to ramp up Covid vaccine manufacturing ( STAT ) As experts debate boosters, vaccinated people are calling their own shots ( Washington Post ) Heather Bresch, Joe Manchin’s daughter, played direct part in Epipen price inflation scandal ( The Intercept ) Novavax begins early-stage trial for combined influenza/COVID-19 vaccine ( R...
  • Sponsored ContentSponsored Content

    Bold thinking and flexibility for marketing application preparation

    My experience over the past decade managing the timelines of the marketing application preparation process has taught me two main lessons. First, no two marketing applications (NDA, BLA, NDS, MAA, etc.) projects are the same. Second, all marketing application projects can benefit from the same set of three guiding principles. Before you begin your next marketing application project, consider carefully whether you have covered these three critical bases for a succe...
  • Regulatory NewsRegulatory News

    Analyses reveal wide variation in PRO measures in cancer trials

    The passage of 21st Century Cures Act in 2015 helped to bolster the inclusion of patient experience data and specifically patient reported outcome (PRO) measures in clinical trials. But even with an increased emphasis on patient reported data, analyses of registrational trials for cancer therapies have shown wide variation in how PRO measures are included and analyzed. A recent analysis of registrational trials for multiple myeloma treatments submitted to the US Food ...
  • Regulatory NewsRegulatory News

    News in Focus: PDUFA VII is a step in the right direction for the rare disease community

    Craig Martin is chief executive officer of Global Genes, a nonprofit organization whose mission is to increase public awareness for rare disease and globally connect, empower and educate individuals and rare disease foundations in person, print and online. More than 400 million people worldwide are affected by 7,000+ rare diseases. In the U.S., around 1 in 10 people (more than 33 million Americans) have a rare condition. More than half of rare disease patients are chi...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA takes Medtronic to court over alleged unlawful supply of medical device

    Australia’s Therapeutic Goods Administration (TGA) has begun legal proceedings against Medtronic Australasia over the alleged unlawful supply of the Infuse Bone Graft Kit. TGA is accusing Medtronic of unlawfully supplying 16,290 kits to 108 hospitals between September 2015 and January 2020.   Medtronic registered the kit in the Australian Register of Therapeutic Goods (ARTG) in 2005 for use in spinal fusion procedures in skeletally mature patients with degenerative dis...
  • ReconRecon

    Recon: EMA reviewing data on Pfizer booster shot; Roche, Adaptimmune sign $3B deal for off-the-shelf cell therapies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer on track for US vaccine boosters, Moderna lagging, Fauci says ( Reuters ) Israel to present COVID-19 booster shot data to FDA experts ( Reuters ) Biden’s Covid booster shot plan mired in confusion amid regulatory hold-ups ( FT ) Calls grow for FDA to speed authorization of kid Covid-19 vaccines ( Politico ) White House Seeks $65 Billion for ‘Apollo’ Pl...
  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • ReconRecon

    Recon: US to invest $3B in COVID vaccine supply chain; EU ends dispute with AstraZeneca over vaccine deliveries

     Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US to invest $3 bln in COVID-19 vaccine supply chain -White House official ( Reuters ) Health Officials Advise White House to Scale Back Booster Plan for Now ( NYTimes ) FDA retirements reignite debate over Biden booster plan ( The Hill ) Analysis: Are COVID boosters needed? FDA vaccine advisers wrestle with a thorny issue ( Reuters ) FDA nod for Janssen schizo...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • Regulatory NewsRegulatory News

    Animal models have limitations for safety assessment of gene therapies: FDA adcomm

    An advisory committee to the US Food and Drug Administration (FDA) has said animal models are “problematic” in assessing the safety risks of gene therapies derived from adeno-associated virus (AAV) vectors.   FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) held a virtual meeting on 2 September to discuss the best animal models to study to assess safety of these products.   “AAV are a popular type of gene therapy, yet we are seeing a variety o...