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  • Regulatory NewsRegulatory News

    FDA trims reserve testing quantity requirements

    Reflecting changes in testing technology, a new and immediately effective guidance from the US Food and Drug Administration (FDA) updates the agency’s approach to retention of reserve samples for bioavailability and bioequivalence testing, generally reducing the amount of drug product that applicants must retain.   An interim rule issued in 1990 and made final in 1993 required applicants or contract research organizations (CROs) to retain an amount of test article and ...
  • Regulatory NewsRegulatory News

    Draft AML guidance takes targeted therapies into account

    The US Food and Drug Administration(FDA)  has issued a new draft guidance for developers of drugs and biologics to treat acute myeloid leukemia (AML).   The new draft guidance takes into account a shift in the treatment landscape for AML as new targeted treatments are being developed for this and other cancers. "In some cases, these newer approaches may extend survival without the prospect for cure, but extending survival may be a meaningful benefit for patients who wo...
  • Feature ArticlesFeature Articles

    FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic

    This article discusses the evolution and implementation of the emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for diagnostic devices during the COVID-19 pandemic in the United States. The author suggests that this limited oversight will affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the ...
  • Regulatory NewsRegulatory News

    Penalty policy for trial reporting violations finalized

    The US Food and Drug Administration has finalized guidance for civil money penalties it may levy for clinical trial data bank reporting violations.   The final document follows a September 2018 draft that addressed the question of how FDA’s Centers should deal with responsible parties who breach federal regulations requiring accurate and complete registration of clinical trials and reporting of results on the www.clinicaltrials.gov website.   This final guidance ...
  • Regulatory NewsRegulatory News

    Unauthorized home COVID test kits targeted by FDA

    Several companies marketing a variety of home tests for COVID-19 were warned by the US Food and Drug Administration (FDA) for misbranding and impermissible marketing. The letters, issued this week, gave the firms 48 hours to take corrective action.   The FDA warned US-based AkivaMed on 23 July for offering a “COVID-19 Antibody Rapid Test Kit” to consumers for at-home blood test collection and analysis.   “We remind you that, to date, FDA has not approved, cleared...
  • Regulatory NewsRegulatory News

    Stakeholders call for regulatory clarity in rare disease research network

    Stakeholders weighing in on a proposed rare disease clinical trials network called for regulatory clarity, smart use of existing resources, and a move toward harmonized trial standards and assessments.   As part of the launch of the US Food and Drug Administration (FDA)’s Rare Disease Cures Accelerator , the agency asked for stakeholder input on how FDA and other agencies can achieve a more cooperative approach in supporting the drug development pipeline for rare dise...
  • RoundupsRoundups

    FDA Roundup: Blenrep, Olinvyk, Lampit

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Blenrep okayed for multiple myeloma in heavily pretreated adults GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf injection) has received accelerated approval for relapsed or refractory multiple myeloma in adults with previous failed treatments, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody.   Blenrep ...
  • Regulatory NewsRegulatory News

    Device importers' COVID questions answered by FDA

    The US Food and Drug Administration (FDA) has launched two new webpages related to medical device importation, registration and listing during the COVID-19 pandemic.   The first webpage addresses registration and listing of medical devices, answering frequently asked questions (FAQs) about what is required, and what procedures should be followed, during the pandemic.   In the question-and-answer format, FDA collates information and guidance documents pertinent to o...
  • Regulatory NewsRegulatory News

    Hahn: COVID-19 vaccine decision will be "deliberative"

    The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be “based on good science and sound data.”   “Nothing else will be used to guide our decisions,” said Stephen Hahn, MD, speaking at a virtual meeting held by the Reagan-Udall Foundation on 10 August.   Hahn delivered prepared remarks along with American Medical Association president Patric...
  • Regulatory NewsRegulatory News

    FDA guides drug-drug interaction studies for therapeutic proteins

    A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins.   The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) recommends that sponsors use a “systematic, risk-based” approach to determine whether their therapeutic protein candidates for investigational new drug applications (IND...
  • Regulatory NewsRegulatory News

    Pandemic prompts mask, ventilator EUAs from FDA

    This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use surgical masks and provided updated information on “in-use time” for certain drugs used to treat patients with COVID-19, the novel coronavirus.   Ventilator-related EUAs The US Food and Drug Administration (FDA) on 4 August issued EUAs for three devices that relate to mechanical ventilation o...
  • Regulatory NewsRegulatory News

    FDA updates bioresearch monitoring e-submission guide

    A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.   The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework la...