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    IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

    Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delay...
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    Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca COVID antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House zeroes in on Califf to head FDA as deadline nears ( Washington Post ) U.S. FDA advisers weigh case for COVID-19 vaccine booster shots ( Reuters ) ( STAT ) J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study ( Reuters ) ( NBC ) Data from Federal Scientists Raise Questions About J.&J. Booster Shots ( NYTimes ) Biden official warn...
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    Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in Congo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Data suggests mRNA booster dose generates stronger antibody response after J&J shot – Axios ( Reuters ) Relying on J&J's analyses to assess vaccine booster dose data -U.S. FDA staff ( Reuters ) ( NYTimes ) US FDA staff says Moderna did not meet all criteria for COVID-19 boosters ( Reuters ) Vaccine requirements raised COVID-19 vaccination rates by 20 percentag...
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    Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck seeks first U.S. authorization for COVID-19 pill ( Reuters ) Roche says Alzheimer's therapy gets U.S. breakthrough designation ( Reuters ) U.S. CDC advisers to review Moderna, J&J COVID-19 booster shots this month ( Reuters ) Govt to control distribution of GSK/Vir COVID-19 antibody in U.S. – FDA ( Reuters ) Adamas, Flexion sell for $825M combined as de...
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    Recon: EU says Russia delayed EMA Sputnik V inspections; FDA approves ChemoCentryx's Tavneos for rare autoimmune disease

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's biomedical research agency dropped from social spending bill ( Politico ) ChemoCentryx's drug gets US FDA nod for treating rare autoimmune disease ( Reuters ) FDA's antimicrobial adcomm unanimously backs Takeda's drug for post-transplant cytomegalovirus ( Endpoints ) Newly revealed texts from ex-FDA leader Stephen Hahn offer behind-the-scene glimpse in...
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    FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths

    The US Food and Drug Administration (FDA) on Thursday reclassified surgical staplers and staples for internal use from Class I (general controls) to the more stringent Class II (special controls) after a 2019 review of adverse events linked the devices to reports of hundreds of deaths and thousands of injuries.   With the final reclassification order in place, surgical staplers for internal use must now undergo premarket review and will be subject to special controls b...
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    Recon: Pfizer, BioNTech request vaccine EUA for children 5-11; Moderna plans African vaccine manufacturing site

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer vaccine for children may be ready by Thanksgiving -White House adviser ( Reuters ) Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11 ( Reuters ) ( WSJ ) ( Politico ) Tensions grow between Moderna, White House over vaccine production ( Politico ) Moderna Wants Fed. Cir. Help to Avoid Covid Vaccine Patent Suits ( Bloomberg ) Biden c...
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    FDA revises guidance on hospital, health system compounding

    Five years after issuing draft guidance detailing its enforcement policy toward hospitals and health system pharmacy compounding under section 503A of the Federal Food, Drug, and Cosmetic Act , the US Food and Drug Administration (FDA) has revised its approach to give more flexibility to hospitals and health systems and to address compounded drugs that are essentially copies of commercially available drugs.   "We understand that compounded drugs can serve an important...
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    Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Africa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Polarean Imaging says FDA rejects new drug application, shares slump ( Reuters ) FDA center directors on lessons from the EUA pathway: Flexibility serves us well ( Endpoints ) Troubled Voyager’s gene therapy relaunch gets a boost with $630M Pfizer deal ( Endpoints ) FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm ( Endpoints ) A...
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    FDA finalizes long delayed de novo classification rule

    The US Food and Drug Administration (FDA) on Monday issued a final rule setting requirements for the medical device de novo classification process, codifying procedures and criteria for new types of medical devices to be authorized as Class I or Class II devices.   "These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also i...
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    Recon: AstraZeneca seeks EUA for preventative COVID antibody; EMA considers rolling review for Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows ( Reuters ) J&J files for authorization of COVID-19 vaccine booster ( Reuters ) AstraZeneca Submits Preventive Covid-19 Treatment for FDA Authorization ( WSJ ) ( Reuters ) Pharmacy chains failed to prevent opioid misuse, U.S. jury hears ( Reuters ) Henrietta Lacks' estate says ph...
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    Recon: J&J will reportedly seek authorization for boosters this week; Pfizer loses suit over copay assistance programs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US McKinsey Never Told the FDA It Was Working for Opioid Makers While Also Working for the Agency ( ProPublica ) Gilead and Kite nab another approval for Tecartus, as leading CAR-T portfolio continues to grow ( Endpoints ) U.S. Supreme Court rejects challenge to New York tax on opioid companies ( Reuters ) Pharmacy chains face first trial over US opioid epidemic ...