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  • ReconRecon

    Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies ( Pink Sheet ) Experts Warn U.S. Could See New Coronavirus Hot Spots ( NPR ) Biden says 65% of people 65 or older have received at least one COVID vaccine shot ( Reuters ) Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary ( Endpoints ) New HH...
  • Regulatory NewsRegulatory News

    CBER sets strategic priorities through 2025

    Facilitating product development, conducting research, boosting preparedness against health threats and organizational excellence top the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) strategic goals for the next five years.   Those goals are detailed in CBER’s 42-page strategic plan, released Wednesday, and account for new legislation and scientific advances since the center’s previous interim plan for FY2017-2019. That le...
  • Regulatory NewsRegulatory News

    FDA offers real-world evidence examples in device applications

     The US Food and Drug Administration (FDA) is offering a detailed look at how real-world evidence sources – from registries to claims data – can be used to support marketing applications for medical devices.   A new report from the FDA’s Center for Devices and Radiological Health (CDRH) breaks down 90 examples in which real-world evidence was used to support final premarket or postmarket regulatory decisions from Fiscal Year 2012 through 2019. These examples include ...
  • Regulatory NewsRegulatory News

    FDA authorizes first COVID test via traditional review pathway

    The US Food and Drug Administration (FDA) on Wednesday authorized the first diagnostic for COVID-19 using a traditional review process, paving the way for more tests to gain clearance through the agency’s 510(k) pathway.   After authorizing hundreds of SARS-CoV-2 diagnostics under emergency use authorizations (EUAs), FDA has authorized the BioFire Respiratory Panel 2.1 (RP2.1) for the simultaneous detection and identification of multiple respiratory viral and bacterial...
  • Regulatory NewsRegulatory News

    Updated: FDA smooths the path for COVID screening tests

    Editor’s note: This story has been updated to include remarks and perspective from an FDA Town Hall for test developers.   At the one-year mark of the public health emergency of the pandemic, the US Food and Drug Administration (FDA) is providing a smoother road to the authorization of COVID-19 tests to screen asymptomatic individuals.   On Tuesday, FDA issued a fact sheet for those who are interested in setting up screening programs, an update to its FAQ do...
  • Regulatory NewsRegulatory News

    CDER missing more BsUFA target dates amid pandemic

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) faced a mountain of work and logistic challenges during the COVID-19 pandemic. While the agency met most of its user fee goals, its performance in moving original biosimilar applications along fell short of the pace it kept in other areas.   A new report from CDER tracks how well the agency fared in acting on applications by type and by quarter, looking at the last two quarters o...
  • RoundupsRoundups

    FDA Approvals Roundup: Fotivda, Kimyrsa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fotivda nabs approval for pretreated, advanced renal cell carcinoma Aveo’s Fotivda (tivozanib ) has been approved for treating relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have received two or more systemic therapies.   Approval for the kinase inhibitor was supported by efficacy findings from the randomized, open-...
  • Regulatory NewsRegulatory News

    FDA launches FAERS dashboard for COVID-19 therapies

    The US Food and Drug Administration (FDA) has launched a new public dashboard to track adverse event reporting for drugs and therapeutic biological products that have received emergency use authorization (EUA) to treat COVID-19.   The FDA Adverse Event Reporting System (FAERS) public dashboard for COVID-19 EUA products will be updated weekly, according to FDA’s landing page for the new initiative.     In its inaugural week, the dashboard indicates that a total ...
  • Regulatory NewsRegulatory News

    Government and pharma search for post-pandemic silver linings

    Where will biopharmaceutical research head once the pandemic abates? This week, the Milken Institute assembled leaders from federal agencies, nonprofit organizations, and the pharmaceutical industry for an hour-long discussion to answer the question of whether there may be post-pandemic silver linings for biomedical innovation.   Though some things were done right, some things could have been done better, said Janet Woodcock, MD, acting commissioner of the US Food and ...
  • Regulatory NewsRegulatory News

    MCIT: Not a better way to pay for breakthrough devices

    The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine .   MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Admi...
  • Regulatory NewsRegulatory News

    FDA calls in adcomm to review six more oncology accelerated approvals

    After drugmakers voluntarily withdrew four indications for their cancer drugs in recent months, the US Food and Drug Administration (FDA) on Thursday said it would convene an advisory committee to review six more oncology indications with accelerated approval after confirmatory trials failed to verify their clinical benefit.   Over the course of three days in April, FDA’s Oncology Drugs Advisory Committee (ODAC) will review six indications for Roche’s Tecentriq (atezol...
  • Regulatory NewsRegulatory News

    Orphan product designation requests climb in the US, remain steady in the EU

    The number of new requests for orphan drug designation in the United States increased 41% from 2019 to 2020, bringing the number of requests to 753 for 2020, according to the U.S. Food and Drug Administration.   There was also a significant jump in rare pediatric disease designation requests, which rose 330% from 2019 to 2020, for a total of 284 requests in 2020. The agency received 20 humanitarian use device designation requests, similar to the number received in 2019...