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    Federal charges levied against COVID "vaccine" peddler

    Federal criminal charges have been filed against a man previously warned by the FDA for peddling unproven and unauthorized “vaccines” against COVID-19.   Johnny Stine, president of Oregon-based North Coast Biologics, previously received a May 2020 warning letter jointly issued by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). In the letter, the agencies ordered him to cease “misrepresentations” made on Facebook and LinkedIn, as well a...
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    Brexit, medicine availability top EMA stakeholder report

    Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.   The EMA report , released Friday and covering the 2018-19 biennium, was presented to EMA’s Management Board in December 2020. It provides a high-level look at interaction between the European regulator and the pharmaceutical indu...
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    Biden’s day one regulatory freeze

    Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.   Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), e...
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    Amid pandemic, EMA's 2020 authorizations ticked upward

    Despite the pandemic, the European Medicines Agency (EMA) issued many more positive recommendations for human medicines in 2020 than in the previous year, according to a new report from the agency highlighting the year’s regulatory activities.   In 2020, 97 new medicines were recommended for authorization by EMA; of these, 39 contain a new active substance (NAS). In 2019, EMA issued 66 positive opinions for medicines, 30 of which contained a NAS. The total numbers of n...
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    Novavax COVID vaccine takes first step toward Australian approval

    Australia’s Therapeutic Goods Administration (TGA) has given a provisional determination to the COVID-19 vaccine being developed by Novavax. This first step means only that the sponsor can apply for provisional registration with TGA, clearing the path for submission of clinical data that may meet criteria for provisional approval.   The Australian provisional approval pathway allows drugs or vaccines to enter the market with “preliminary clinical data,” without the sub...
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    FDA guides on COVID considerations in cell and gene therapy

    Manufacturers of cell and gene therapies have a new guidance from the US Food and Drug Administration (FDA) that provides pandemic-related manufacturing considerations.   The guidance specifically addresses both licensed and investigational cell and gene therapy (CGT) manufacture, and “is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s ‘Good Manufacturing Practice Considerations for Responding to COVID-19 Infect...
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    Woodcock takes charge as acting FDA commissioner

    Janet Woodcock, the long-serving director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is officially the agency’s acting commissioner and is reportedly being considered for the Biden administration’s permanent pick for the role.   Hours after the presidential inauguration, Woodcock tweeted , “It is an honor and privilege” to serve as acting commissioner. “The FDA’s public health work is more critical than ever as we ...
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    HHS, FDA dispute spills out onto Twitter

    In the final months and weeks of the Trump administration, the Department of Health and Human Services (HHS) has advanced several policies to consolidate its authority over the US Food and Drug Administration’s (FDA). Today, with just one day left in the Trump administration, the latest dispute between HHS and its subagency spilled into the public. Following media reports last week that FDA Commissioner Stephen Hahn refused to sign a memorandum of understanding (Mo...
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    CBER lays out volume-staff mismatch in PDUFA VII meetings

    During an 11 December public stakeholder meeting, FDA met with representatives of patient and consumer advocacy groups as the Prescription Drug User Fee Act (PDUFA) VII reauthorization process continues.   The meeting, held virtually, began with a review of the cell and gene therapy review programs overseen by FDA’s Center for Biologics Evaluation and Research (CBER). Wilson Bryan, MD, of CBER’s Office of Tissues and Advanced Therapies (OTAT), told attendees at the vir...
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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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    FDA allows modifications to coagulation monitoring systems for COVID-19

    The US Food and Drug Administration (FDA) is allowing manufacturers to modify coagulation systems for measuring whole blood viscoelastic properties to allow for greater use in hospitals for the supportive management of patients with COVID-19.   The enforcement policy , which was issued in January 2021, is temporary and will remain in effort only for the duration of the COVID-19 public health emergency.   “As hypercoagulability has been observed in patients with CO...
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    Perspective: Drug price transparency in the Biden era

    The Trump administration’s efforts to increase drug price transparency are likely to survive the transition to the Biden administration, according to a perspective piece published 13 January in the New England Journal of Medicine . Included in the Transparency in Coverage final rule, issued in late October 2020, the drug price transparency provisions aim to require that health insurers publish list prices and historical net prices for prescription drugs. The inform...