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  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Dozens of vaccines now have been authorized or approved around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that a...
  • Regulatory NewsRegulatory News

    FDA officials reflect on quality maturity model, quality metrics

    The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said an agency official, the results of which will help inform the development of a future rating program.   Michael Kopcha, director of FDA’s Office of Pharmaceutical Quality (OPQ) also told a recent webinar that the public should not confuse quality metrics with QMM. Kopcha and other officials discu...
  • Regulatory NewsRegulatory News
    This Week at FDAThis Week at FDA

    This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, FDA announced the dates for three upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to review the Moderna and Pfizer/BioNTech vaccines for younger children, Novavax’s COVID-19 vaccine and SARS-CoV-2 strain composition for modified vaccines. ...
  • Regulatory NewsRegulatory News

    IVDR implementation day overshadowed by lack of notified bodies, risks to patients

    While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle the influx of conformity assessments necessitated by the new regulation.   On 26 May, medtech manufacturers, notified bodies and regulators woke up to a brave new world where IVDR is the law of the land. Under the regulation, new diagnos...
  • Regulatory NewsRegulatory News

    Euro Convergence: SSCP expert lists common mistakes device manufacturers make

    AMSTERDAM – Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but such issues tend to be persistent, said Rachel Gibbs, principal regulatory consultant at NAMSA, during this year’s RAPS Euro Convergence meeting in Amsterdam.   Beyond her current role at NAMSA, where she advises companies on how to comply with notified body requirements, Gibbs also has experience as...
  • RoundupsRoundups

    Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO

    The European Medicines Agency (EMA) is set to suspend around 100 generic medicines that came to market based on data from “flawed” bioequivalence studies run by the contract research organization (CRO) Synchron Research Services.   Officials at the US Food and Drug Administration stopped accepting data from studies by the Indian CRO last year over data integrity concerns. EMA’s Committee for Medicinal Products for Human Use (CHMP) recently completed its own investiga...
  • ReconRecon

    Recon: Lawmakers grill Califf on response to infant formula crisis; Supply chain, China lockdowns cloud Medtronic’s outlook

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lawmakers grill U.S. FDA on response to Abbott baby formula safety ( Reuters ) ( NYTimes ) The next U.S. abortion battle is over pills, and it's already begun ( Reuters ) Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors ( KHN ) A no good, very bad week for the FDA ( STAT ) Eli Lilly set to invest $2.1B in home state manufacturing b...
  • RoundupsRoundups

    FDA Approvals Roundup: Vtama, Dupixent, Vidaza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Vtama approved as topical, steroid-free treatment for plaque psoriasis in adults Dermavant’s VTAMA ( tapinarof; cream, 1% ) has been approved as a steroid-free, topical treatment for adults with mild-severe plaque psoriasis.   Approval of the aryl hydrocarbon receptor agonist was based on findings from the Phase 3, multicenter, double-blind, ...
  • Regulatory NewsRegulatory News

    Medtech groups want more time to implement FDA’s QMSR rule

    Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international quality system standard, but they want more than a year to make the transition.   In February, FDA published a long-awaited proposed Quality Management System Regulation (QMSR) rule to harmonize its regulatory requirements for medical device quality systems contained in 21 CFR part 820 with the international stan...
  • Regulatory NewsRegulatory News

    FDA issues Q&A on importation of prescription drugs from Canada

    The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.   In final guidance , issued on 25 May 2022, the agency provided 12 questions and answers aimed at providing a plain language guide to implementation of the Importation of Prescription Drugs final rule, which became effective on 30 November 2020. That regulation was aimed at reducing prescription drug costs by impl...
  • Regulatory NewsRegulatory News

    House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections

    Republicans in the House Committee on Energy and Commerce have sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf asking him to provide information about drugs approved solely based on data from clinical trials conducted in China and details about FDA trial site inspections in China. In their letter, Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-FL), and H. Morgan Griffith (R-VA), said they are concerned about an increase of FDA dr...
  • ReconRecon

    Recon: Teva, Allergan reach $161.5M opioid settlement with W. Virginia; Pfizer pledges to sell drugs at no profit in low-income countries

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Teva, Allergan reach $161.5 million opioid settlement with West Virginia ( Reuters ) CVS Will Stop Filling Controlled-Substance Prescriptions for Cerebral, Done ( WSJ ) 'Hands may be tied': FDA slaps Verrica with 3rd CRL due to problems with contract manufacturer ( Endpoints ) GSK 'schemed' FDA's drug-device approval pathway to deflect asthma inhaler generics,...