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    Should the US government share the Moderna COVID vaccine recipe?

    As much of the developing world struggles to gain access to COVID-19 vaccine doses, some legal experts say the key lies in having the US government share the step-by-step instructions for manufacturing and testing the Moderna mRNA vaccine with other manufacturers.   In a recent Health Affairs blog , Christopher J. Morten, Zain Rizvi, and Ameet Sarpatwari made the case that the US government, through its contract with Moderna, has both access to the details of how the ...
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    WHO revises guidance on GMPs for investigational products, R&D facilities

    The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well a new draft guideline addressing GMP principles for research and development facilities in the context of the COVID-19 pandemic.   The draft guidance on GMPs for investigational products was prompted by WHO’s Prequalification Team Inspections Services (PQT), which last year expressed the need...
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    FDA seeks comments on regulation of kratom, 6 other drugs

    Kratom, a popular but unregulated psychotropic herbal extract, is one of seven currently unscheduled psychotropic drugs that will be reviewed by the World Health Organization (WHO) under the provisions of the international psychotropic convention to which the US is a party.   WHO notified the US and other international parties to the 1971 convention that the seven new psychotropic drugs may be added to its list of scheduled drugs. By law, that notification triggers a r...
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    Recon: Biden and Democrats face dilemma on vaccine mandates; EU to discuss joint recognition of vaccine certificates with Russia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA narrows patient group for Biogen's Alzheimer's drug ( Reuters ) Alzheimer antibody rush begins, as efficacy concerns remain ( Nature ) AstraZeneca-Amgen drug gets FDA speedy review as asthma treatment ( Reuters ) Death rates are declining for many common cancers in the U.S., report finds ( STAT ) HHS head: 'Absolutely the government's business' to kn...
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    EMA gives procedural guidance on variant COVID vaccines

    A new document from the European Medicines Agency (EMA) will give vaccine developers procedural guidance when the time comes for them to update COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.   The procedural guidance was adopted by EMA’s human medicines committee on 24 June, and is meant to apply to vaccines against other human coronaviruses as well. Marketing authorization holders may submit a variation to change the composition of a CO...
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    Global regulators issue call for clinical trial data transparency

    World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines.”   Data related to a therapy or vaccine “must be published at the time of finalization of the regu...
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    EMA finalizes guidance on parallel MAA, EU-M4all procedure

    The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).   The guidance was adopted earlier this month following a public consultation launched in January and includes some minor changes from the draft version. (RELATED: EMA offers parallel Article 58, centralized authorization reviews , Regulatory Focus ...
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    EMA, WHO investigate reported clots with AstraZeneca vaccine

    As countries in Europe and elsewhere continue to pause administration of the AstraZeneca COVID-19 vaccines over reports of clotting events in recipients, the European Medicines Agency (EMA) announced Monday that it worked through the weekend to analyze and make sense of these reports.   Continuing a “rigorous analysis of all the data related to thromboembolic events,” EMA announced that its safety committee (PRAC) will hold an extraordinary meeting on Thursday, 18 Ma...
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    WHO/IAEA tackle investigational radiopharmaceutical GMP in draft guidance

    The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) have released a draft guideline on good manufacturing practices for investigational radiopharmaceuticals.   The March 2021 document is the first working draft of a revision to the existing guidelines on good manufacturing practices (GMP) for investigational products. Consultation is open through the end of April 2021, with a revised document expected to be worked up for public consu...
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    AstraZeneca COVID vaccines receive WHO emergency use listing

    The World Health Organization (WHO) has granted two additional vaccines against COVID-19 emergency use listing (EUL). Two versions of the vaccine co-developed by AstraZeneca and the University of Oxford received EUL status from WHO on Monday, following an all-day meeting and one the previous Friday to weigh safety and efficacy recommendations and manufacturing and quality considerations.   The two vaccines had to be considered separately, said WHO director-general Tedr...
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    WHO's Essential Diagnostics List updated for COVID-19

    The World Health Organization (WHO) updated its list of essential diagnostics for 2021 on Friday to include recommendations for polymerase chain reaction and antigen-based diagnostic tests for COVID-19.   In making this and other recommendations to the “basket of recommended in vitro diagnostics” that makes up the organization’s Essential Diagnostic List (EDL), WHO also recommended additional tests that detect disease preventable by vaccines and other infectious dise...
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    WHO updates COVID vaccine and clinical care guidelines

    The World Health Organization (WHO) has released recommendations that include the use of low-dose anticoagulants for hospitalized patients with COVID-19 to reduce the risk of venous thromboembolism. That recommendation accompanies four other updates to the agency’s “living guidance” document for clinical management of patients with COVID-19.   For inpatients, the specific anticoagulation regimen recommended is thromboprophylaxis-level dosing rather than intermediate or...