• ReconRecon

    Recon: FDA asked J&J to discard 60M vaccine doses made at Emergent plant; EMA adds rare blood condition as side effect of AZ shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA tells J&J that 60M doses made at Emergent plant cannot be used ( NYTimes ) ( Reuters ) ( Politico ) J&J vaccine doses to be released, but many will be tossed ( AP ) ( Axios ) ( FDA ) FDA faces mounting criticism over Alzheimer’s drug approval ( Reuters ) Eli Lilly memo says firm did not make false statements to FDA ( Reuters ) Controversial drug approval ...
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    Author offers advice for navigating combination products approval pathways

    With few comprehensive resources available covering combination products, RAPS’ recently released book, International Combination Products , by Jocelyn Jennings, MS, RAC (US, Drugs, Devices), fills a significant need for practical guidance on navigating the regulatory pathways for products combining multiple technologies. Prior to writing the book, “there was no place that I found that I could look to find all of the information I was interested in on different topics t...
  • ReconRecon

    Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to donate 500 million Pfizer doses to poor nations ( Reuters ) ( Politico ) US is in discussions with Moderna on buying Covid vaccine doses for other nations ( CNBC ) Moderna files for US authorization to use its COVID-19 vaccine in teens ( Reuters ) ( NYTimes ) FDA extends shelf life of Johnson & Johnson COVID-19 vaccine ( Reuters ) Ocugen to file for ful...
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    RAPS' LatestRAPS' Latest

    RAPS announces board slate; Cooper, Salditt to serve second terms

    The RAPS nominating committee has selected the slate of new members set to join the board for the term beginning 1 January 2022, following careful review of all nominations for two open director positions. Following are the two incoming directors: Carol Cooper , MS, RAC, IM(ASCP), RM(AAM), principal, CM Cooper and Associates Diana Salditt , FRAPS, independent regulatory advisor, (formerly) senior program director, Medtronic  Both Cooper and Salditt are current fi...
  • Regulatory NewsRegulatory News

    IVDR: MDCG charts rollout in new implementation plan

    The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) set to take effect next May.   With the date of application of the Medical Devices Regulation (MDR) now in the rear view, MDCG’s attention is turned to challenges on the horizon related to IVDR. MDCG previously released a joint implementation plan for MDR in March 2020, bef...
  • RoundupsRoundups

    Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID

    Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.   The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals...
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    May’s Regulatory Focus: EU MDR and EU IVDR update, and more

    Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application ...
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    FDA releases draft guidance on assessment of PROs for cancer trials

    The US Food and Drug Administration (FDA) has released a draft guidance that recommends how sponsors can collect “meaningful” patient-reported outcome (PRO) measurements to assess results from cancer clinical trials.   The draft guidance focuses on a set of “core” PRO measures that can be used to gather data on patients’ symptoms, symptomatic adverse events and physical function and is specific to registration trials for anti-cancer treatments intended to demonstrate...
  • ReconRecon

    Recon: US signs for $1.7M courses of Merck’s experimental COVID drug; FDA approves Vertex CF drug for 6-11 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says he will be announcing a vaccine plan for the world ( Reuters ) White House urges states to seek longer shelf life for J&J shots as millions near expiration ( Reuters ) ( KHN ) ( Politico ) US signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug ( Reuters ) ( HHS ) Vertex cystic fibrosis treatment gets U.S. approval for use i...
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    FDA disappointed with slow uptake of approvals for stem cell therapies

    At a recent meeting, a US Food and Drug Administration official said the agency is “concerned” about the slow uptake from companies seeking regulatory approval to market and distribute stem cell therapies and is therefore stepping up their enforcement efforts against companies making unapproved therapies.   Wilson Bryan, director of FDA’s Office of Tissues and Advanced Therapies (OTAT) in FDA’s Center for Biologics Evaluation and Research, told attendees of an 8 June m...
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    FDA Approvals Roundup: Aduhelm, Brexafemme, Tembexa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Aduhelm okayed for slowing Alzheimer’s by targeting disease-driving process Biogen’s Aduhelm (aducanumab) has received accelerated approval for treating patients with Alzheimer’s disease, making it the first new treatment for the disease since 2003.   The human monoclonal antibody is also a first-of-its kind therapy for the disease in that...
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    Friends of Cancer Research project tracks early cancer therapy response

    The Friends of Cancer Research (FCR) has launched the next stage of a project that studies whether circulating tumor DNA changes can be used to track early response to cancer therapies.   The launch of Step 2 of the Circulating Tumor DNA for Monitoring Treatment Response (ctMoniTR) Project will involve data collection from over 3,000 cancer patients participating in more than 25 studies, said FCR in announcing the launch. Sixteen additional cancer treatments involving ...