• Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: Record-shattering 2020 healthcare investment; BIO layoffs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Who’s who in Biden’s health care team ( Medical Economics ) Biden begins presidency with aggressive healthcare agenda ( Healthcare IT News ) Biden Inherits a Vaccine Supply Unlikely to Grow Before April ( NYT ) Biden administration is trying to figure out what’s delaying Covid vaccine shots, CDC says ( CNBC ) How To Fix The Covid-19 Vaccine Rollout ( Forbes )...
  • Regulatory NewsRegulatory News

    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 ...
  • RoundupsRoundups

    FDA Approvals Roundup: Xalkori, Darzalex Faspro, Enhertu

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Xalkori gets expanded indication for advanced anaplastic large-cell lymphoma in young patients Pfizer’s Xalkori (crizotinib) has been approved for treating relapsed or refractory systemic, ALK-positive anaplastic large cell lymphoma (ALCL) in patients aged 1 to 21 years. The drug’s safety and efficacy has not been established in older adults w...
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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’s AI/ML action plan includes ‘tailored’ regulatory framework for SaMD

    The US Food and Drug Administration has released a five-part action plan for its oversight of artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) based on feedback from developers and manufacturers on an April 2019 discussion paper.   Top of the action-plan list is the agency’s intention to develop a “tailored” regulatory framework for the medical software by issuing draft guidance on the Predetermined Change Control Plan outl...
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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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    PREPP initiative: FDA’s COVID-19 response and the path forward

    The US Food and Drug Administration (FDA) has adapted in its response to the COVID-19 pandemic, from increasing transparency of its risk-benefit analyses for emergency use authorizations (EUAs) to providing guidance on vaccine development, according to a summary report of the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.   The report catalogues the agency’s work during the pandemic, noting that it has published and revised more than 65...
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    FDA sped progress for most of 2020's novel drugs

    Most novel drugs approved by the US Food and Drug Administration (FDA) in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals.   Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 20...