• Regulatory NewsRegulatory News

    CDRH outlines guidance plans for FY2022

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearances from last year's list.   As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft and final guidances, which CDRH says it will publish as res...
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    Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children ( Reuters ) Becton Dickinson begins selling new at-home rapid COVID-19 test ( Reuters ) Latest psilocybin patent highlights the swirling battle over psychedelics intellectual property ( STAT ) US will require foreign travellers to get WHO-authorised vaccines ( FT ) NIH enlisted to help FDA assess...
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    Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet with Califf as commissioner search narrows

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden meets with top FDA candidate ( Politico ) FDA Says Pfizer Vaccine’s Benefits Outweigh Key Risks in Children 5 to 11 ( NYTimes ) ( STAT ) Moderna says its COVID-19 vaccine protective, safe in young children ( Reuters ) ( STAT ) US to invest $70 mln to boost access to COVID-19 tests ( Reuters ) Bausch, Clearside receive US approval for eye injection ( Reu...
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    Recon: Pfizer says COVID vaccine is 90.7% effective in children 5-11; Oncopeptides pulls Pepaxto after failing confirmatory trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Walgreens U.S. stores start administering Moderna, J&J COVID-19 booster ( Reuters ) Americans can mix and match COVID-19 boosters but original vaccine recommended -Fauci ( Reuters ) C.D.C. Recommends Covid Booster Shots for Millions of Americans ( NYTimes ) ( STAT ) Pfizer/BioNTech COVID-19 vaccine shows 90.7% efficacy in trial in children ( Reuters ) Oncopep...
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    FDA withdraws more than 200 ANDAs over unsubmitted annual reports

    Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday said it will withdraw 216 of those applications.   The withdrawals follow a notice of opportunity for hearing (NOOH) FDA published in January 2020 that listed 249 applications from 89 drugmakers with delinquent annual reports. (RELATED: ...
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    Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Moderna, J&J Covid-19 boosters, allows mix-and-match shots ( Politico ) ( Reuters ) ( FDA ) A C.D.C. panel is meeting for debate on boosters and the ‘mix-and-match’ strategy. ( NYTimes ) A 30-Year Campaign to Control Drug Prices Faces Yet Another Failure ( NYTimes ) Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large ...
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    Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US ‘They rushed the process’: Vaccine maker Novavax's woes hamper global inoculation campaign ( Politico ) ( Reuters ) Novavax expresses fresh confidence in its vaccine ( Politico ) Biogen banks on government coverage to restart stalled Alzheimer's drug sales ( Reuters ) Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations ( STAT ) Cigna's p...
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    Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA proposes over-the-counter hearing aids for Americans ( Reuters ) ( FDA ) Pfizer-BioNTech’s vaccine is highly effective against hospitalization for those 12 to 18, a study shows. ( NYTimes ) J&J keeps vaccine sales outlook unchanged after third-quarter miss ( Reuters ) FDA to Allow ‘Mix and Match’ Approach for Covid Booster Shots ( NYTimes ) ( Reuters ) At...
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    Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA considering lowering recommended age for Pfizer/BioNTech COVID-19 boosters ( Reuters ) FDA delays decision on Moderna's COVID-19 vaccine for adolescents ( WSJ ) ( Reuters ) FDA declines to approve Revance's frown-line treatment ( Reuters ) ( Endpoints ) Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes ( Reuters ) ( Endpoints ) ...
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    CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.   The recommendations include positive opinions for four medicines and one generic, as well as conditional authorization for Janssen's Rybrevant (amivantamab) for the treatment of non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations.   The recomme...
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    Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers to vote on J&J vaccine booster ( Reuters ) FDA advisers back Moderna COVID booster shots for older and high-risk people ( Reuters ) ( NYTimes ) Abbott Labs unit recalling two COVID-19 lab test kits – FDA ( Reuters ) As suits mount, J&J spins out talc liabilities into Chapter 11 using 'Texas two-step' maneuver ( Endpoints ) ( FT ) FDA to Hold...
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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...