• Regulatory NewsRegulatory News

    FDA tallies pandemic inspection toll, issues new 'resiliency roadmap'

    A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.   “The numbers reveal the state of our inspectional oversight and how we plan to address postponed inspectional work using a risk-based approach,” wrote acting FDA director Janet Woodcock, MD, in a forward to the Resiliency Roadmap for FDA Inspectional Oversight .   ...
  • RoundupsRoundups

    FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Higher-dose Kloxxado nasal spray cleared for countering opioid overdose Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose. Its indicated dose of 8 mg is notably higher than the previously approved doses of 2 and 4 mg for other naloxone nasal spray products.   Kloxxado was approved thro...
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    FDA welcomes alternative approaches to generic drug development

    Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Generic Drugs, said at a 5 May webinar on the development of product specific guidance.   FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of G...
  • ReconRecon

    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...
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    Panelists: Sluggish pace of DSCSA testing is worrisome

    In a recent traceability forum, the pharmaceutical industry and other trading partners were told to start testing their data systems now to ensure that any glitches are ironed out before prescription drug products must be electronically tracked through the supply chain to ward off counterfeiting. The Drug Supply Chain Security Act (DSCSA) mandates that these systems go live in November 2023.   To ensure readiness, panelists participating in the 29 April Healthcare Dist...
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    BsUFA talks continue on technology, regulatory science and reviews

    The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.   During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (RELATED: FDA, Industry set priorities for BsUFA III , R...
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    Pfizer COVID vaccine under EMA review for younger teens

    The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years.   Pfizer reported that it submitted its application for extension of authorization last week, and EMA announced today that it has undertaken the evaluation of the messenger RNA (mRNA) vaccine. The vaccine has been authorized by the EU for use in people 16 years and up since December 2020.   Trials of ...
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    CDER regulatory science division touts 2020 accomplishments

    In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.   “2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory wo...
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    ODAC recommends pulling 2 of 6 accelerated approvals

    “Dangling” accelerated approvals of cancer immunotherapies were on the docket for a 3-day session of the US Food and Drug Administration’s oncology advisory committee that wrapped up on 29 April. After 2 days of relatively smooth sailing for the first half of the six indications on the docket, the final day saw two recommendations for withdrawal – and unexpected fireworks from FDA staff.   Of six indications put before ODAC, just two were recommended for withdrawal, de...
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    FDA scraps another last-minute Trump-era policy

    The US Food and Drug Administration (FDA) on Friday revoked a policy issued in the final days of the Trump administration that was purportedly aimed at increasing transparency related to drug review timelines.   The policy, announced by the Department of Health and Human Services (HHS) on 15 January 2021, would have required FDA to publish “redundant” information on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the agency for...
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    FDA, industry make opening bids in BsUFA III negotiations

    The US Food and Drug Administration says that meeting goals related to industry meetings “continues to be a challenge” in its negotiations with industry on the third iteration of the Biosimilar User Fee Act (BsUFA III) program for FY2023-27.   BsUFA, originally enacted in 2012, authorizes FDA to collect fees from biosimilar developers to help fund the agency’s review program. As with the agency’s other user fee programs, FDA and industry negotiate terms for the agree...
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    Regulators discuss expectations and challenges in conducting virtual inspections

    Regulators from the US Food and Drug Administration and the European Medicines Agency gave an update on desktop and virtual inspections and offered some advice on ensuring smoother audits at a 28 April webinar.   While there seemed to be acceptance among regulators that virtual and desktop inspections are a reality until the COVID-19 public health emergency is over, a larger group of health officials at the webinar said that onsite inspections are much better at uncove...