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  • Regulatory NewsRegulatory News

    DIA/FDA Forum: CBER's pandemic journey continues

    Crushing workloads and statistical conundrums characterized the work of FDA’s staff as they raced to formulate guidelines and then evaluate vaccine candidates amid the pressure of the pandemic, attendees at a biostatistics conference heard on Wednesday.   More complex analysis awaits as real-world vaccine data roll in and FDA’s Center for Biologics Evaluation and Research (CBER) and sponsors both work toward full biologic license applications (BLAs) for the vaccines th...
  • Regulatory NewsRegulatory News

    ASCO-Friends meeting: NCI offers strategies to modernize cancer trials

    In a conversation hosted by the Friends of Cancer Research and the American Society of Clinical Oncology, cancer researchers spoke with regulators and industry to lay out ways to modernize cancer clinical trial eligibility criteria. Further, advances in use of real-world evidence and remote data collection may eventually reduce reliance on the classical clinical trial, according to some attendees.   During the 9 April webinar, attended by US Food and Drug Administratio...
  • Regulatory NewsRegulatory News

    FDA, CDC recommend J&J vaccine pause while rare clots investigated

    In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have recommended that administration of the one-dose Johnson & Johnson COVID-19 vaccine be paused.   The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced cerebral venous sinus thrombosis (CVST) – a blood clot in a larg...
  • Regulatory NewsRegulatory News

    Cavazzoni named to permanent CDER director role

    Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER).   The appointment, announced on Twitter Monday morning, comes after Cavazzoni spent the past year as acting director of CDER. She was appointed to the position when Janet Woodcock, MD, left to assume her role leading the therapeutics arm of the COVID-19 accelerator Operation Warp Speed (OWS).   “Pleased to announce the perma...
  • Regulatory NewsRegulatory News

    Woodcock: Post-COVID, new flexibility could boost cancer trial diversity

    Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet Woodcock, MD, the acting commissioner of the US Food and Drug Administration (FDA). Woodcock spoke Friday at a webinar co-hosted by Friends of Cancer Research and the American Society of Clinical Oncology,   At the meeting, whose focus was how to improve patient access and repres...
  • Regulatory NewsRegulatory News

    "Very rare" thrombotic events with AZ vaccine, concludes EMA's PRAC

    AstraZeneca’s COVID-19 vaccine may have a “very rare” but serious side effect of unusual blood clotting with a low blood platelet account, concluded the safety committee of the European Medicines Agency (EMA). The benefits of receiving the vaccine still outweigh risks, said the committee, hewing to the line EMA has held to throughout the investigation into reports of clotting events with the AstraZeneca vaccine.   The conclusion reached by EMA’s Pharmacovigilance Ris...
  • Regulatory NewsRegulatory News

    FDA withdraws 5 opioid ANDAs for no REMS or reports

    Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.   The action comes after the holders of the abbreviated new drug applications (ANDAs) “have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” wrote FDA in announcing the withdrawal.   T...
  • Regulatory NewsRegulatory News

    PDUFA VII postmarketing talks focus on REMS, Sentinel

    As the US Food and Drug Administration (FDA) and industry worked through FDA commitments for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), a series of meetings in early 2021 defined where postmarketing priorities would lie. Risk evaluation and mitigation, best uses of the Sentinel safety system, and a pregnancy demonstration project were top of mind for both industry and FDA.   Recently released minutes from three additional meetings o...
  • ReconRecon

    Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines ( NIH ) ( Reuters ) CDC says variant from the UK is now the most common strain circulating in the U.S. ( CNBC ) U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director ( Reuters ) U.S. surpasses 150 million vaccine shots under Biden, on track to hit President’s new 2...
  • Regulatory NewsRegulatory News

    Manhattan firm's "allergy drops" prompt CBER untitled letter

    The US Food and Drug Administration’s (FDA’s) biologics division has delivered an untitled letter to a Manhattan-based firm for marketing sublingual “allergy drops” from its Fifth Avenue address.   Curex, Inc. was the recipient of the missive sent 23 March by the Office of Compliance and Biologics Quality in FDA's Center for Biologics Evaluation and Research (CBER). On its website , Curex claims that its sublingual immunotherapy drops “are made using the same ingredie...
  • Regulatory NewsRegulatory News

    Biosimilars industry weighs in on BsUFA II interim assessment

    Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.   The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication fo...
  • FDA, EMA team up on pediatric oncology drug development template

    In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric cancer drugs.   A new Common Commentary template gives a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on new Pediatric Investigation Plans ...