• Regulatory NewsRegulatory News

    CDRH outlines plan to understand sex and gender differences in medical devices

    The US Food and Drug Administration (FDA) has finalized its strategic plan for incorporating sex and gender differences into the development and regulation of medical devices. The Health of Women Program Strategic Plan , released on 18 January 2022, outlines priorities for integrating the health of women into the research and regulatory work of FDA’s Center for Devices and Radiological Health (CDRH). The strategic plan finalizes a proposal released in September 2019. ...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic wears on, a handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/Ro...
  • Regulatory NewsRegulatory News

    This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some newly published data from FDA on its user fee program performance, REMS programs and generic drug approvals.   A new FDA guidance on diversity plans to improve the enrollment of underrepresented racial and ethnic groups in clinical trials may see the light o...
  • Regulatory NewsRegulatory News

    European Parliament endorses legislation bolstering EU’s ability to tackle shortages

    The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.   The measure advanced by a 655-31 vote, with eight abstentions. The legislation is based on an agreement reached last October between Parliament and the European Council on changes intended to improve the management of future health crises and shortages of drugs and medical devices. (RELATED: EU Par...
  • ReconRecon

    Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US preparing for possible future COVID variants -White House ( Reuters ) The scientists, they’re learning more’: A defiant Biden defends the CDC amid mounting criticism ( STAT ) Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA ( Pink Sheet ) FDA adds all blood sample collection tubes to medical device shortage list ( Reute...
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    FDA offers examples of innovative study designs accepted into CID pilot

    The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meeting program.   The aim of presenting the case studies is to help sponsors understand factors that should be considered when proposing a CID. The pilot program was launched in 2018 to accelerate the development of therapies for unmet med...
  • RoundupsRoundups

    Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation

    The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove unnecessary burdens to clinical trial sponsors.   Having left the European Union before the implementation of the Clinical Trials Regulation, the UK is free to plot its own course as it seeks to establish itself as the best place to rese...
  • RoundupsRoundups

    FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ryaltris okayed for seasonal allergic rhinitis Glenmark’s Ryaltris ( olopatadine and mometasone furoate; nasal spray ) has been approved for seasonal allergic rhinitis in adults and pediatric patients aged 12 years or older.   The approval of Ryaltris was based on findings from two multicenter, randomized, double-blind, placebo-and active-co...
  • ReconRecon

    Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Finance chair investigates Bristol Myers over an allegedly abusive overseas tax shelter ( STAT ) ‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals ( The Pink Sheet ) Pfizer says COVID-19 antiviral pill effective against omicron ( The Hill ) US to make 400 million N95 masks available for free to fight COVID-19 ...
  • Regulatory NewsRegulatory News

    FDA extends temporary halt in inspections driven by omicron

    The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.   FDA previously announced it would halt certain inspectional activities out of concern for its employees and those of the companies it regulates amid the wave of COVID-19 infections driven by the omicron variant. At the time, the agency said it would continue to c...
  • Regulatory NewsRegulatory News

    Califf, experts eye legislative fix for accelerated approval program

    Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might be necessary to reliably get results from these trials in a timelier manner.   Robert Califf, head of clinical policy and strategy for Verily and Google Health and the Biden Administration’s nominee to be FDA commissioner, said a legisla...
  • Regulatory NewsRegulatory News

    Califf previews priorities if confirmed as FDA commissioner

    In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better postmarket evidence generation.   The senators, Roger Marshall (R-KS) and Mike Braun (R-IN), were two of the eight lawmakers on the Senate Health, Education, Labor, and Pensions (HELP) committee who voted against Califf’s nomination. Fa...