• Regulatory NewsRegulatory News

    FDA publishes two critical DSCSA draft guidances

    The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the pharmaceutical supply chain, while the other guidance pertains to identifying trading partners that are authorized to track products though the supply chain.   The agency announced that “these documents are critical steps toward implement...
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    VRBPAC recommends addition of Omicron-component to future boosters

    A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated strain composition in hopes that vaccine targeting a more recent strain of the virus will be more effective.   FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 28 June to discuss whether the a...
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    FDA official: Virtual audits, records requests may be sticking around

    CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting ...
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    FDA authorizes Pfizer, Moderna vaccines for youngest children

    The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.   This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Mode...
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    Back to the drawing board for FDA’s revised quality metrics plan?

    The US Food and Drug Administration’s (FDA) revised plan to collect quality metrics data from manufacturers drew criticism from one major pharmaceutical industry group on the metrics the agency is proposing, as well as its methods for developing the program. Others complained that the proposed program lacks focus, while two industry groups also expressed serious misgivings about the purpose of the overall program.   Yet on a positive note, one industry group and major ...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
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    Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests

    Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the amount of regenerative medicine advanced therapy (RMAT) requests approved for cell and gene therapies to sponsors “getting the hang” of the agency’s expectations for designation requests.   Marks spoke at the California Separation Science Society’s (CASSS) meeting on 8 June on cell and gene therapies. The meeting was h...
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    Cavazzoni: Pandemic-era tools, learnings are here to stay

    The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...
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    Experts say FDA enforcement focus unchanged, use of alternative tools to grow

    The US Food and Drug Administration (FDA) will continue to focus on data integrity practices and take a hard look at OTC firms’ testing programs either through onsite inspections or using alternative inspection tools in fiscal year 2022, according to experts who spoke to Regulatory Focus on near-term enforcement trends.   In addition, industry should expect to continue fielding requests for electronic records as the agency’s use of this alternative inspection tool is...
  • RoundupsRoundups

    FDA Approvals Roundup: Evrysdi, Kymriah, Tibsovo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Evrysdi gets label extension for use in babies with spinal muscular atrophy Genentech’s Evrysdi ( risdiplam; powder for oral solution ) has been granted a new indication to include babies younger than 2 months with spinal muscular atrophy (SMA).   The approval is based on interim findings from the RAINBOWFISH study in newborns demonstrat...
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    FDA and EMA mostly align on GCP inspection deficiencies, study finds

    A study conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) found that the agencies are identifying the same types of deficiencies in joint good clinical practice (GCP) inspections with respect to protocol compliance, documentation deviations, and human subject protections.   The paper follows a mutual transatlantic cooperation on GCPs between the regulators that went into effect on 1 September 2009. Under the program, regulators ...
  • Feature ArticlesFeature Articles

    FDA ‘high-risk’ foreign inspections: Post‒COVID-19 response to GMP challenges

    This article examines the US Food and Drug Administration’s (FDA) return to inspections that were put on hold during the ongoing COVID-19 pandemic. It outlines the agency’s oversight of drug and biological products during the pandemic and its plans moving forward. The authors summarize the agency’s guidance and policies, industry considerations, and recommendations to manufacturers preparing for their next FDA inspection.   Keywords FDA, inspections, quality, risk m...