• Regulatory NewsRegulatory News

    FDA Approvals Roundup: Cabenuva, Lupkynis, Verquvo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Cabenuva  approved as first extended-release, injectable regimen for adults with HIV ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine injection) has been approved as a long-acting, once-monthly regimen for patients HIV-1 infection.   The extended-release regimen is indicated for patients with virologic suppression who are on a stable ...
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    FDA puts all Mexican hand sanitizers on import alert

    The US Food and Drug Administration (FDA) has placed all hand sanitizers from Mexico on import alert over concerns of methanol contamination. “This marks the first time the FDA has issued a countrywide import alert for any category of drug product,” noted FDA a press release announcing the measures.   The alert will “help stop products that appear to be in violation from entering the US until the agency is able to review the products’ safety,” according to the press r...
  • Regulatory NewsRegulatory News

    CDER lays out 2021 guidance agenda

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021.   The agenda, while oftentimes aspirational, provides insights as to what the agency’s drug center’s new guidance priorities are for the coming year. However, the list does not include draft or revised guidances the agency plans to finalize in 2021. (RELATED: 2020 CDER draft and revised guidance...
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    A look at FDA’s data on priority and competitive generics

    Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations. The FDA Reauthorization Act of 2017 (FDARA), which reauthorized GDUFA for five years, includes provisions to shorten the reviews of certain ANDAs...
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    Inspections down in 2020, but CDER hit most goal dates

    During the pandemic, the US Food and Drug Administration (FDA) continued to attempt to meet goals mandated by its various user fee programs – and, generally, the agency succeeded, though a steep drop in inspections hampered some efforts.   The details of how well FDA’s Center for Drug Evaluation and Research (CDER) met its user fee commitments were laid out in a 26 January report covering the third and fourth quarters of federal fiscal year 2020 (FY20), which ended 3...
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    OPDP's Gray reflects on 2020's challenges, successes

    Looking back to 2020, the acting director of the US Food and Drug Administration’s Office of Prescription Drug Promotion (FDA’s OPDP) highlighted the office’s major initiatives and successes.   Speaking in a “Conversations” interview hosted by FDA’s Center for Drug Evaluation and Research, Katie Gray, PharmD, spoke of inter-agency initiatives to encourage biosimilar competitiveness, how the pandemic changed the year’s course for OPDP, and future directions.   In th...
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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...
  • 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 )...
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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 ...
  • 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...