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  • Regulatory NewsRegulatory News

    Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine

    The public should have confidence in any COVID-19 vaccine approved by the US Food and Drug Administration (FDA), according to the testimony presented by five top pharmaceutical executives at a hearing of the House Energy & Commerce Subcommittee on Oversight and Investigations on 21 July.   The executives – representing AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer – also stressed that the agency does not appear to be lowering its standards to rush a vacci...
  • Regulatory NewsRegulatory News

    FDA kicks off GDUFA III reauthorization process

    In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency’s third GDUFA program.    GDUFA II, authorized in 2017, expires at the end of September 2022. The GDUFA II agreement had two major objectives in speeding access to ...
  • ReconRecon

    Recon: Drugmakers boost lobbying amid pandemic rush; Biogen to study Spinraza in patients treated with Zolgensma

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma Firms Boost Lobbying in Race for Virus Treatment, Vaccine ( Bloomberg ) ( STAT ) US Accuses Two Hackers of Stealing Secrets From US Firms for China ( WSJ ) White House to resurrect rebate rule ( Politico ) Biogen to study Spinraza in combination with $2 million Novartis drug ( Reuters ) ( Press ) Gilead lines up a $1.55B biotech buyout deal as CEO Dan ...
  • RoundupsRoundups

    Asia-Pacific Regulatory Roundup: TGA finds ‘clear examples’ of harm linked to medical software

    Reviews conducted by Australia’s Therapeutic Goods Administration (TGA) found “clear examples” of harm caused by medical software.   TGA searched the medical literature for articles on the safety and efficacy of medical software as part of an assessment of how it regulates the sector. In parallel, the administration reviewed its data, revealing that software faults caused 20% of all medical device recalls over the past five years. While the recalls primarily related to...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    Elemed and RAPS announce a partnership for Elemed’s Mentoring Academy

    RAPS and Elemed, a leading European technical recruiter in the medical technology industry, have signed a partnership to offer Elemed’s Mentoring Academy to RAPS members at special rate. With the first program launching in September, Elemed’s Mentoring Academy is the first of its kind—a hybrid mentoring and training program—specifically designed for regulatory, quality and clinical professionals within the MedTech and in vitro diagnostics (IVD) industry. “The goal of th...
  • Regulatory NewsRegulatory News

    Six more months tacked onto regenerative medicine enforcement date

        The end of a discretionary enforcement period for regenerative medicine products was pushed back by another 6 months, according to a final guidance issued today by the US Food and Drug Administration (FDA).   Today’s updated guidance shifts the enforcement date but otherwise leaves unchanged a 2017 guidance addressing regulatory considerations for “minimal manipulation” and “homologous use” of human cells, tissues and cellular and tissue-based products (HCT/P...
  • Regulatory NewsRegulatory News

    FDA issues enforcement policy for coronavirus transport media

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.   The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW ...
  • Regulatory NewsRegulatory News

    New EMA pharmaceutical water quality guideline takes effect February 2021

    The European Medicines Agency (EMA) on Monday issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021.   The adoption of the guideline follows a public consultation that kicked off in November 2018, with EMA making mostly minor changes to the guideline aside from revisions to the table listing minimum acceptable quality o...
  • Regulatory NewsRegulatory News

    FDA approves pooled sampling for COVID-19 test

    Pooled sampling of COVID-19 swab specimens is now allowed under a reissued emergency use authorization (EUA) for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, the US Food and Drug Administration (FDA) announced on 18 July.   Under the reissued EUA, four samples may be processed together in a batch, reducing the number of tests run and using fewer testing supplies. If the pooled sample is negative, no more testing would be required. If the pooled sample is positive, th...
  • ReconRecon

    Recon: Oxford, CanSino coronavirus vaccines trigger immune response; GSK buys 10% stake in CureVac

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House seeks to block funds for coronavirus testing and tracing in relief bill ( CNBC ) Mistrust of a Coronavirus Vaccine Could Imperil Widespread Immunity ( NYTimes ) Inside Johnson & Johnson’s nonstop hunt for a coronavirus vaccine ( NYTimes ) More than 100,000 have signed up for coronavirus vaccine testing ( The Hill ) Gene Therapy Shows Promise For H...
  • Regulatory NewsRegulatory News

    Project Patient Voice a focus of ASCO-FDA workshop

    A day-long workshop co-sponsored by the US Food and Drug Administration (FDA) and the American Society for Clinical Oncology (ASCO) focused on clinical outcome assessments in cancer clinical trials. A key topic of the day’s work was the pilot version of Project Patient Voice , a new attempt to create a flexible, searchable, accurate, and understandable website for members of the public who wish to learn about patient experience data. The website is meant to give patients ...
  • Regulatory NewsRegulatory News

    Updates on MDR implementation, transparency; MDCG posts CEAR template

    The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation.   The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medic...