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  • ReconRecon

    Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar

    ​Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC ( Pink Sheet ) J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? ( Endpoints ) Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA ( Global Genes ) Kymera Therapeutics, fresh ...
  • Regulatory NewsRegulatory News

    FDA clarifies pooled sample, multi-analyte coronavirus EUAs

    Developers of multi-analyte respiratory panels that include a test for SARS-CoV-2, the novel coronavirus, can request emergency use authorizations (EUAs) from the US Food and Drug Administration (FDA), the agency clarified this week.   In updates to its frequently asked questions (FAQ) webpage on SARS-CoV-2 testing, the agency said that multi-analyte respiratory panels that include SARS-COV-2 are eligible for emergency use authorization, noting “the overlap in signs ...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • Regulatory NewsRegulatory News

    Glycolic acid, TCA among proposed additions to 503B bulk drugs list

    Four new bulk substances are up for inclusion on the list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under section 503B of the Federal Food, Drug, and Cosmetic Act , according to a proposal from the US Food and Drug Administration (FDA).   The four substances FDA is proposing to include as bulk drug substances are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. An additiona...
  • Regulatory NewsRegulatory News

    FDA issues new unit-dose repackaging guidance

    Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met.   The agency issued the guidance in the context of the increasingly common practice of repackaging solid oral medications into unit-dose containers for hospitals and long-term care facilities. “The increase in unit dose repackaging has led to questions...
  • Regulatory NewsRegulatory News

    FDA issues at-home and OTC COVID-19 testing template

    Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and Drug Administration (FDA).   For at-home testing, the template includes recommendations for developers in the scenario where samples are collected, analyzed, and results returned without the sample being sent to a laboratory for analysis. Additional validation recommendations are...
  • Regulatory NewsRegulatory News

    FDA addresses endotoxin levels in investigational cancer treatments

    Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug Administration.   The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally admi...
  • RoundupsRoundups

    FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tecartus okayed as first CAR-T therapy for MCL Kite’s Tecartus (brexucabtagene autoleucel), a customized, one-time therapy derived from a patient’s genetically modified T cells, has received accelerated approval for treating adults with relapsed or refractory mantle cell lymphoma (MCL).   It is the first chimeric antigen receptor T-cell (CAR...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...
  • Regulatory NewsRegulatory News

    $3.2 billion FDA budget clears US House

    The US House of Representatives passed a four-bill appropriations minibus for fiscal year 2021 that includes an amendment giving the US Food and Drug Administration (FDA) the authority to recall drugs. The agency’s proposed budget also includes targeted boosts to spending for medical product and food safety activities and influenza vaccine manufacturing technologies.   Other targeted initiatives include cross-departmental initiatives designed to enhance food and medica...
  • Regulatory NewsRegulatory News

    Excipients group seeks GDUFA III participation

    Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said Priscilla Zawislak, Immediate Past-Chair of International Pharmaceutical Excipients Council (IPEC)-Americas.   Zawislak, speaking at the 21 June 2020 public hearing kicking off the reauthorization process for the third Generic Drug Fees User Amendments (GDUFA III), said that excipient manufacturers are also a...
  • Feature ArticlesFeature Articles

    US regulations for regenerative medicine advanced therapies

    This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that it is expanding at an accelerated pace, and outlines some of the common terms associated with it. He also addresses the application process for these therapies, accelerated regulatory pathways, market access, and the outlook for RMATs. The author cautions that, as exciting as these therapies a...