• 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

    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...
  • ReconRecon

    Recon: Lilly says antibody drug prevented COVID in nursing home study; Biden to invoke Defense Production Act

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden leaves top FDA job open amid vaccine push ( Politico ) Lilly Antibody Drug Prevents Covid-19 in Nursing Homes, Study Finds ( WSJ ) ( STAT ) U.S., staying in WHO, to join COVID vaccine push for poor nations: Fauci ( Reuters ) California resumes Moderna COVID-19 vaccine usage after pause ( Reuters ) Biden dissolves Covid-19 panel that advised his transiti...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: WHO says three COVID vaccines in final review for EUL; Hahn’s exit interviews

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Outgoing FDA chief: The agency fought 'substantial' pressure under Trump ( Politico ) Trump FDA Chief Was 'Disgusted' by Riots, Stayed to Guide Agency: Q&A ( Bloomberg ) “A Tsunami of Randoms”: How Trump’s COVID Chaos Drowned the FDA in Junk Science ( Vanity Fair ) Janet Woodcock to Lead FDA on Interim Basis ( WSJ ) Biden to hit reset on nation's fight agains...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: Independent review critical of delayed pandemic response; US Supreme Court rejects Merck hep C patent appeal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Small biotech launches human trials of a potential ‘backstop’ for Covid-19 vaccines ( STAT ) Will the FTC get tougher on pharma business practices under the Biden administration? ( STAT ) Supreme Court rebuffs Merck appeal in hepatitis C patent fight with Gilead ( Reuters ) ( Law360 ) Mylan loses bid to dismiss EpiPen antitrust claims ( Reuters ) How Operatio...
  • Regulatory NewsRegulatory News

    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...