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  • Regulatory NewsRegulatory News

    FDA to Pilot Interactive 510(k) Template

    As part of its commitments under the Medical Device User Fee Amendments (MDUFA IV), the US Food and Drug Administration (FDA) on Wednesday announced a pilot to test a new, interactive, PDF-based 510(k) template.   According to FDA, the electronic Submission Template and Resource (eSTAR) features automation, integration with other resources and a structure that is more aligned with the Center for Devices and Radiological Health’s (CDRH) internal review templates.   ...
  • ReconRecon

    Recon: Schumer Calls for $8.5B for Coronavirus Response; Takeda Buys PvP in $330M Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House considers appointing coronavirus czar ( Politico ) Schumer Requests $8.5B for Coronavirus Response ( Senate ) Trump will hold White House news conference on coronavirus on Wednesday ( Reuters ) Candidates attack Trump on coronavirus ( Politico ) First US Testing Begins for Potential Coronavirus Treatment ( WSJ ) GoodRx Saves Money on Meds, Also S...
  • Regulatory NewsRegulatory News

    FDA Monitoring 20 Drugs at Risk of Shortage due to Coronavirus

    As part of its efforts to ensure the supply of medical products from China during the ongoing coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) has identified 20 drugs that are made in or produced solely from active pharmaceutical ingredients (APIs) sourced from China.   In a statement to Focus , FDA spokesperson Stephanie Caccomo said the agency has been in contact with the companies that make the 20 products and that “none of these firms has...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) waivers for their tests or conduct studies to support dual 510(k) and CLIA waiver by application submissions.   FDA first issued draft versions of the guidances in 2017, in line with provisions of the 21st Century Cures Act and the Medical Device User Fee Amendments (MD...
  • ReconRecon

    Recon: Trump Administration’s $2.5B Coronavirus Ask Faces Criticism From Both Parties

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House seeks $2.5B for coronavirus, but Pelosi says that's not enough ( NBC ) ( Reuters ) Trump officials clash with senators over coronavirus response ( Politico 1 , 2 ) Tired of delays, US labs ask FDA to develop their own coronavirus tests ( Reuters ) US plans trial of Gilead coronavirus drug remdesivir ( CNBC ) ( NIH ) ICER appears to have a change ...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
  • Regulatory NewsRegulatory News

    Coronavirus: Will the Outbreak Lead to US Drug Shortages?

    A media report of potential drug shortages because of the ongoing novel coronavirus (COVID-19) outbreak has one senator sending a letter to the US Food and Drug Administration (FDA) seeking answers.   On Sunday, Axios reported that FDA has compiled a list of about 150 drugs that are at risk of shortage because of COVID-19.   In response, Senator Josh Hawley (R-MO) on Monday sent a letter to FDA asking the agency what it is doing to head off any potential short...
  • ReconRecon

    Recon: FDA Approves Esperion Cholesterol Treatment, Lundbeck Migraine Drug; ICER Partners With Aetion for Patient Data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Coronavirus threatens shortages of about 150 drugs ( Axios ) White House to ask Congress for emergency coronavirus funding ( Politico 1 , 2 ) Local Officials in AL, CA Resist Plans to House Coronavirus Patients ( NYTimes ) ( Reuters ) ( NBC ) Companies in pharmaceutical supply chain develop system to track counterfeit drugs ( Reuters ) Gilead Surges After WH...
  • Regulatory NewsRegulatory News

    Drug Approvals: FDA Publishes Dataset of CDER Approvals Since 1985

    To provide researchers with more accurate and accessible data about historic drug approvals, the US Food and Drug Administration (FDA) on Friday released a dataset containing information about all new drugs and biologics approved by the Center for Drug Evaluation and Research (CDER) dating back to 1985.   “FDA created the compilation to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug,” FDA writes, addin...
  • Regulatory NewsRegulatory News

    FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

    The US Food and Drug Administration (FDA) on Friday finalized the seventh revision to its guidance on making regulatory submissions in electronic common technical document (eCTD) format to specify cases where an exemption or waiver from eCTD requirements is warranted.   The 17-page guidance finalizes a draft version released in July 2019 and replaces the previous final version from January 2019.   Within the guidance, FDA says it will exempt all Type III drug m...
  • ReconRecon

    Recon: Canada Weighs Changes to Drug Pricing Rules; No AdComm for Biomarin’s Valrox

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioMarin gene therapy won't need an AdComm as it nabs speedy FDA review ( Fierce ) ( Endpoints ) ( Press ) Stalled Initiatives to Cut Drug Prices Frustrate Trump ( WSJ ) Gilead loses another challenge to a pair of US patents for an HIV prevention pill ( STAT ) ( Endpoints ) Bankrupt antibiotics maker Aradigm turns to old partner/investor for final $3M fire sal...
  • Regulatory NewsRegulatory News

    Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions

    The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations.   “Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded...