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  • This Week at FDAThis Week at FDA
    Regulatory NewsRegulatory News

    This Week at FDA: House advances user fee bill, FDA’s enterprise modernization ambitions, and another 510(k) pilot

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. It was a busy week for FDA on the Hill again, with FDA Commissioner Robert Califf testifying before the House Appropriations committee on Thursday and the House Energy & Commerce committee voting unanimously to send FDA user fee and reform legislation to the House floor.   On Thursday...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocilizumab), Paxlovid (ni...
  • Regulatory NewsRegulatory News

    FDA asks manufacturers to develop risk management plans to avert shortages

    The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also recommends risk factors to consider when developing the content of the RMPs.     Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), FDA was given new authorities to collect information from manufacturers in respond...
  • Regulatory NewsRegulatory News

    FDA explains plans to bolster cell and gene therapy approvals through wider messaging

    Wilson Bryan director of the US Food and Drug Administration’s Office of Tissues and Advanced Therapies (OTA) in the agency’s Center for Biologics Evaluation and Research, told a 19 May meeting  of the Association for Cell and Gene Therapies (ASGCT) that the division is undertaking a series of internal measures to improve communications with sponsors and to widen its messaging.   These measures are being taken to compensate for a lack of individual attention to applic...
  • Regulatory NewsRegulatory News

    Califf uses budget hearing to advocate for resources, authority to monitor supply chains

    A House appropriations subcommittee hearing on the proposed budget for the US Food and Drug Administration placed the agency’s commissioner, Robert M. Califf, on the hot seat, taking criticism for failing to prevent an infant formula shortage in the country. In turn, Califf used the opportunity to ask lawmakers for more resources and authority to oversee the supply chains for products the FDA regulates.   Califf testified virtually on 19 May before the House Appropria...
  • RoundupsRoundups

    Euro Roundup: EMA seeks feedback on remote batch certification post-pandemic

    The European Medicines Agency (EMA) has proposed allowing qualified persons (QPs) to remotely certify batches routinely even after pandemic-related travel barriers are over.   When the pandemic hit, manufacturers operated in business continuity mode and EMA posted guidance on regulatory flexibility to enable companies to minimize the risk of shortages while maintaining high standards of quality, safety and efficacy. EMA recognized that QPs needed to adapt to the pandem...
  • ReconRecon

    Recon: CDC advisors discuss widening additional booster eligibility measures; Montreal sees 17 monkeypox cases as European tally increases

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US C.D.C. advisers meet for discussion on whether to recommend Pfizer boosters for children 5 to 11. ( NYT ) ( Reuters ) CDC: Monkeypox Case Reported in the U.S. ( MedPage Today ) ( Reuters ) ( Bloomberg ) House Passes FDA Baby Formula Bill, But Senate Fate Is Uncertain ( Bloomberg ) Biden invokes Defense Production Act to increase supply of U.S. infant formula  ...
  • Regulatory NewsRegulatory News

    Study: Inhaler manufacturers use patents, exclusivity to shut out generic competition

    Brand-name inhaler manufacturers have successfully used patent hops, cross-listed patents, and other nonpatent regulatory exclusivities to keep generic manufacturers out of the US inhaler market over the last 35 years, according to an analysis published in Health Affairs . The result has been higher costs for patients and a lack of innovation, according to the study’s lead author William B. Feldman of Brigham and Women’s Hospital and Harvard Medical School, both in Bos...
  • Regulatory NewsRegulatory News

    User fee reauthorization bill advances in the House, Senate eyes different riders

    The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US Food and Drug Administration’s (FDA) user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one proposed in the Senate because of severe time constraints, according to an industry source with extensive legislative Hill experience.   On 18 May, the Energy and Commerce committee voted to move forward with the much-anticipated Foo...
  • Regulatory NewsRegulatory News

    New report urges more clinical trial diversity, recommends incentives

    A new report commissioned by Congress makes significant recommendations for improving clinical trial diversity, including offering financial incentives that have typically been off the table for ethical reasons. The 403-page report addresses a range of stakeholders but specifically urges the US Food and Drug Administration (FDA) to hold sponsors accountable for enrolling more diverse participants in trials.   On 17 May, the National Academies of Sciences, Engineering a...
  • Regulatory NewsRegulatory News

    FDA updates guidance on evaluating out-of-specification results for drugs

    The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including the responsibilities of the analyst and supervisor in reporting these results.   FDA defines OOS results as “all test results that fall outside the specifications or acceptance criteria established in dug applications, drug master files (DMFs), official compendia, or by the manufacturer. The ter...
  • ReconRecon

    Recon: Senate user fee bill omits accelerated approval measures; NIH to study longer course of Paxlovid to combat reinfections

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House committee unanimously advances FDA user fee legislation with accelerated approval tweaks ( Endpoints ) Senate user fee reauthorization bill omits accelerated approval reforms, shows wide gaps with House version ( Endpoints ) ( The Pink Sheet ) FDA lobbies Congress over rare disease court ruling with wide implications ( Endpoints ) Confirmation for Head o...