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    June’s Regulatory Focus: Nutrition in health and disease management

    Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...
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    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...
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    FDA calls for inclusion of Omicron BA.4/5 in future boosters

    Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winter seasons.   The recommendation follows a 19-2 vote in favor of adding an Omicron-specific component to future boosters by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) earlier this week. (RELATED:...
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    Recon: US signs $3.2B deal for Pfizer-BioNTech vaccines; Novartis said to lean toward spinoff of generics unit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA recommends inclusion of BA.4, BA.5 subvariants in COVID boosters ( Reuters ) As booster season awaits, US re-ups supply of Pfizer Covid-19 vaccine with new $3.2B deal ( Endpoints ) ( Reuters ) ( Fierce ) ( Bloomberg ) Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid ( Reuters ) Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Ad...
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    Recon: Pfizer, BioNTech to test universal coronavirus vaccine; ARCH raises $3B fund for biotech startups

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA's VRBPAC votes in favor of adapting the Covid-19 vaccine to the latest Omicron variant ( Endpoints ) ( STAT ) ( Reuters ) ( The Pink Sheet ) FDA: Don’t rush a move to change the Covid-19 vaccine composition ( STAT ) BioNTech, Pfizer to start testing universal vaccine for coronaviruses ( Reuters ) US Health Officials Announce New Monkeypox Vaccination Plan ...
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    Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel to advise on whether — and how — Covid vaccines should be updated ( STAT ) ( NYTimes ) ( Endpoints ) ( Fierce ) Pfizer/BioNTech say Omicron-based COVID shots improve response vs that variant ( Reuters ) FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation ( Endpoints ) Astellas’ gene therapy...
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    Recon: Moderna touts bivalent booster’s response against Omicron subvariants; EU to raise investment in Latin American drug manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna booster candidate shows strong response against Omicron subvariants ( Reuters ) Moderna CEO: COVID variant vaccine to be ready for shipping in August ( Reuters ) Omicron-specific COVID vaccines on the horizon, Pfizer chief says ( Reuters ) More vulnerable people receiving fewer COVID pills - U.S. study ( Reuters ) FDA to Order Juul E-Cigarettes Off U....
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    Recon: Pfizer to buy 8.1% stake in Valneva, Merck explores Seagen buyout

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID vaccine rollout for US children close after CDC panel vote ( Reuters ) Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing ( STAT ) Comparing the Pfizer and Moderna Covid vaccines for young children ( STAT ) Merck Explores Purchase of Biotech Seagen ( WSJ ) FDA advisors mostly agree that Acadia’s Nuplazid isn't effective...
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    VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children

    On Wednesday, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of amending FDA’s emergency use authorization (EUA) for Moderna’s two-dose vaccine to include children 6 months through 5 years of age. The committee voted separately in favor of recommending to amend Pfizer’s EUA for its vaccine and authorize use of a three-dose vaccine for children 6 months through 4 years of age.   In a 21-0 v...
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    VRBPAC unanimously backs Moderna vaccine for children 6 and up

    The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.   The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adoles...
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    Unannounced FDA inspections in India, China to begin soon

    An official with the US Food and Drug Administration (FDA) announced the agency will soon resume unannounced onsite inspections in India and China. Also, prioritized foreign inspections will resume in February.   Elizabeth Miller, assistant commissioner for medical products and tobacco operations in FDA’s Office of Regulatory Affairs (ORA), provided this update on the agency’s inspection activities at a 9 December virtual conference on enforcement sponsored by the Fo...
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    FDA issued vaccine EUAs without facility inspections: GAO

    Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections before their vaccines were authorized by the US Food and Drug Administration (FDA), said the General Accounting Office (GAO) in a new report. However, most facilities had been inspected at least once previously in past 10 years, and the agency relied on a variety of other information sources including record reviews and on-site reviews.   The examination of th...