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    FDA explains convalescent plasma donor eligibility for COVID vaccine recipients

    The US Food and Drug Administration (FDA) last week revised its guidance on COVID-19 convalescent plasma to clarify when COVID-19 vaccine recipients can qualify as donors for plasma collected under the agency’s emergency use authorization (EUA) for convalescent plasma.   (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA , Regulatory Focus 25 August 2020; COVID convalescent plasma guidance gets EUA updates , Regulatory Focus 3 Septembe...
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    Recon: FDA approves Daiichi’s Enhertu for certain gastric adenocarcinomas; Norway says advice on Pfizer vaccine unchanged

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca, Daiichi's breast cancer drug gets broader US approval ( Reuters ) ( FDA ) Biden will keep Dr. Francis Collins as National Institutes of Health director: statement ( Reuters ) Biden warns of challenges ahead as he rolls out new vaccine plan ( Politico ) Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures’ ( NPR ) ( Polit...
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    Cyberattack: EMA says leaked documents ‘manipulated’

    Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency said on Friday.   EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements ack...
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    FDA issues guidance on resuming or initiating BE studies amid pandemic

    New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.   The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by ...
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    Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vaccine reserve was already exhausted when Trum administration vowed to release it ( Washington Post ) Trump admin races to enact term limits for top health scientists ( Politico ) Trump wants billions cut from global Covid vaccine distributor ( Politico ) Former FDA commissioner: "Reliable drug supply is absolutely critical" ( Axios ) Biden taps D.C. veteran...
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    EMA offers parallel Article 58, centralized authorization reviews

    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend to market in the EU and abroad.   The Article 58 procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to give opinions in cooperation with the World Health Organization (WHO) on medicines intended to be used in low- an...
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    Recon: Woodcock expected as acting FDA commissioner; J&J vaccine induces immune response in early trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job ( BioCentury ) ( Endpoints ) ( Bloomberg ) Biden’s Covid board in the dark on final vaccine plan ( Politico ) Data fuel debate over whether J&J’s one-dose Covid vaccine will measure up ( STAT ) ( Bloomberg ) ( NEJM ) J&J vaccine on track for March rollout with target to delive...
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    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...
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    Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA fights for independence in Trump administration's final days ( Politico ) Johnson & Johnson Expects Vaccine Results Soon but Lags in Production ( NYTimes ) Supreme Court Revives Abortion-Pill Restriction ( NYTimes ) Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say ( CNBC ) US to buy 1.25M additional dos...
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    HHS pushes through last-minute policies impacting FDA

    With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...
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    Updated: FDA’s top lawyer resigns

    Editor's note: This article has been updated to reflect clarification from HHS about who will fill the role of chief counsel. The US Food and Drug Administration’s (FDA) top lawyer, Chief Counsel Stacy Cline Amin, resigned from the agency, effective Monday, according to an email to agency staff from FDA Commissioner Stephen Hahn.   However, the announcement as to who would succeed Cline Amin was met with confusion as the Department of Health and Human Services (HH...
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    Recon: US overhauls vaccine rollout plans; Novartis, BeiGene partner on tislelizumab

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US HHS 'unleashed' in string of last-minute policies ( Politico ) In a last-minute, intra-agency scuffle, HHS overrules FDA pick for a key position ( STAT ) ( Politico ) Pfizer has produced more than 70 million COVID-19 vaccine doses: CEO ( Reuters ) US shifts to speed vaccinations; won’t hold back 2nd doses ( AP ) ( Reuters ) ( Bloomberg ) Democrats demand plan...