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    Capacity adjustments, DMFs under discussion for GDUFA III

    Newly released minutes show progress made during the past two months of negotiations between the US Food and Drug Administration and industry on commitment language for the second reauthorization of the Generic Drug User Fee Amendments (GDUFA III).   In March and April, FDA and industry focused on a number of ongoing issues in seven negotiation meetings. (RELATED: Industry-FDA GDUFA III negotiations seek higher first-round approval rates , Regulatory Focus 11 Novemb...
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    Four FDA guidances related to DSCSA awaiting OMB sign-off

    The Office of Management and Budget (OMB) on 11 May began reviewing a set of guidances related to the US Food and Drug Administration’s (FDA) implementation of the Drug Supply Chain Security Act (DSCSA) .  They address suspect products, product identifiers and interoperable electronic tracing of products.   Under the Paperwork Reduction Act of 1995, federal agencies must regularly submit to the OMB guidance document and regulations for review to ensure their cost-e...
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    FDA finalizes QIDP Q&A guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.   The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designati...
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    FDA authorizes Pfizer-BioNTech vaccine in children 12-15

    The US Food and Drug Administration (FDA) on Monday authorized Pfizer and BioNTech’s COVID-19 vaccine for use in adolescents 12 to 15 years of age.   "The FDA's expansion of the emergency use authorization [EUA] for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock in a statement. "Today's action allows for a younger popul...
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    Shuren updates on inspections, ISO 13485 and MDUFA V

    Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.   The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiolog...
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    Global regulators issue call for clinical trial data transparency

    World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines.”   Data related to a therapy or vaccine “must be published at the time of finalization of the regu...
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    FDA awards two COA grants to study neurodevelopment disorders and nephrotic syndrome

    The US Food and Drug Administration (FDA) announced the awarding of two grants under its Clinical Outcome Assessments (COAs) program to inform the selection of clinical trial endpoints for drugs to treat neurodevelopmental disorders (NDDs) and nephrotic syndrome.   The grants “provide avenues to advance the use of patient input as an important part of drug development that can foster innovation and the availability of safe and effective drugs,” said the agency’s 4 May ...
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    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...
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    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...