• This Week at FDAThis Week at FDA

    This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more

    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 saw FDA approve the first fecal microbiota product, halt the emergency authorization of a COVID-19 antibody and advance guidance on the development of treatments for mpox.   This week, FDA approved Ferring Pharmaceuticals’ Rebyota (fecal microbiota, live-jslm) to prev...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more

    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 heard from FDA Commissioner Robert Califf and Oncology Center of Excellence (OCE) Director Richard Pazdur about FDA’s return to office plans, accelerated approvals and a new initiative called Project Pragmatica.   FDA’s Cardiovascular and Renal Drugs Advisory Committee ...
  • ReconRecon

    Recon: FDA advisers back Ardelyx kidney disease drug; UnitedHealth to offer Humira alongside biosimilars next year

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers back Ardelyx's kidney disease drug ( Reuters ) ( Endpoints ) Lab-grown meat cleared for human consumption by U.S. regulator ( Reuters ) ( FDA ) FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease ( FDA ) Roche gets EUA for high-throughput monkeypox test ( MedtechDive ) ( Reuters ) Elizabeth Holmes’...
  • ReconRecon

    Recon: Walmart to settle opioid suits for $3.1B; Immunogen lands accelerated approval for ovarian cancer drug

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Walmart to Pay $3.1 Billion to Settle Opioid Lawsuits ( WSJ ) AEYE Health gets FDA approval to screen diabetics to prevent blindness ( Reuters ) Immunogen's $6,220 ovarian cancer drug to be shipped within days ( Reuters ) ( STAT ) ( FDA ) U.S. FDA staff flags unclear benefits of Ardelyx's kidney disease drug ( Reuters ) FDA warns of rise in reports of child poisoni...
  • ReconRecon

    Recon: Indivior to acquire Opiant for $145M; Roche Alzheimer’s drug fails in Phase 3 studies

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Moderna's Omicron shots shows better immune response than original COVID vaccine ( Reuters ) ( STAT ) Satsuma Pharma's migraine drug fails late-stage study, shares crash ( Reuters ) U.S. FDA approves AstraZeneca's lung cancer drugs ( Reuters ) Narcan Owner Opiant to Be Acquired by Indivior for $145 Million ( WSJ ) After blazing trails in RNA-targeted drugs, Ionis j...
  • ReconRecon

    Recon: FDA Commissioner Califf tests positive for COVID; Veru surges on hopes for COVID drug EUA

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US U.S. FDA commissioner Robert Califf tests positive for COVID ( Reuters ) ( FDA ) Pfizer’s Covid Cash Powers a ‘Marketing Machine’ on the Hunt for New Supernovas ( KHN ) After years of lax oversight, the NIH is starting to contact institutions about unreported clinical trial results ( STAT ) Amid concerns over U.S. democracy, pharma helped finance committees that sup...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Califf on Twitter, ‘face-to-face’ meetings, and more

    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. To kick off the week, FDA Commissioner Robert Califf tweeted that he and FDA will remain active on Twitter following Tesla CEO Elon Musk’s takeover of the company and concerns about a laxer approach to moderation under Twitter’s new ownership. We also noted FDA’s updated definition of “f...
  • Regulatory NewsRegulatory News

    FDA sends warning letters to Lupin, Amazon and Walmart

    The US Food and Drug Administration (FDA) last month warned Indian generic drugmaker Lupin Limited over three good manufacturing practice (GMP) violations at its facility in Maharashtra, India.   The warning letter stems from an inspection conducted in March and April 2022 that identified issues with the company’s written procedures for equipment cleaning, its written procedures for monitoring and controlling performance of processing steps and the “failure to invest...
  • Regulatory NewsRegulatory News

    This Week at FDA: Former FDA commissioners push for reforms cut from user fee package

    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 saw two former FDA commissioners, Scott Gottlieb and Mark McClellan, call on Congress to pass several legislative reforms that were stripped out of the user fee reauthorization package last month.   Writing in JAMA Forum this week, Gottlieb and McClellan said the ag...
  • ReconRecon

    Recon: FDA confirms widespread Adderall shortages; India finds violations at drugmaker linked to Gambia deaths

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US FDA Confirms Widespread Shortages of Adderall ( NYTimes ) ( Reuters ) Pfizer, BioNTech find updated COVID booster protects against Omicron in trial ( Reuters ) Merck opts to develop, sell cancer vaccine with Moderna ( Reuters ) ( STAT ) Novavax says COVID booster dose shows benefit against Omicron variants ( Reuters ) Relmada's stock sinks after depression drug def...
  • ReconRecon

    Recon: Pfizer, Moderna seek EUA for bivalent boosters for kids; Daiichi Sankyo wins Japanese approval for blood cancer drug Ezharmia

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Moderna asks FDA to authorize omicron Covid boosters for children as young as 6 years old ( CNBC ) ( Reuters ) Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11 ( CNBC ) ( Reuters ) Biden to announce $1.5 billion to fight U.S. opioid crisis ( Reuters ) Monkeypox Appears to Recede, but Risks and Uncertainties Linger ( NYTimes ) Seagen, a...
  • Regulatory NewsRegulatory News

    MDCG offers guidance on ‘appropriate surveillance’ under IVDR transition period

    The European Commission’s Medical Devices Coordination Group (MDCG) last week issued guidance offering in vitro diagnostic makers and notified bodies clarity on what constitutes “appropriate surveillance” of diagnostics during the In Vitro Diagnostic Medical Devices Regulation (IVDR) transition period.   “Devices which are covered by valid certificates issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) may be plac...