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  • Regulatory NewsRegulatory News

    EMA releases final guideline on antibacterial drug development

    The European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that is globally aligned with guidance from other regulators.   EMA said the document addresses a “pressing need for new antibacterial agents suitable for treating infections in patients with few remaining therapeutic options.”   The agency announced that antimicrobial resistance poses a “global threat” and is responsible for an estimated 33,000 deaths per yea...
  • Regulatory NewsRegulatory News

    MDCG sets out transition periods for legacy diagnostics post-IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) has clarified how long legacy devices can remain on the market after the In Vitro Diagnostic Regulation (IVDR) comes into application.   The new timelines are set out in a guideline covering legacy devices that are placed on the market before May 26, which is the date the transition period from the current IVD Directive (IVDD 98/79/EC) ends.   A legacy device is either: a device with an EC certifi...
  • RoundupsRoundups

    Asia-Pacific Roundup: Philippine FDA seeks feedback on abridged procedures for clinical trial applications

    The Philippine Food and Drug Administration (FDA) is planning to offer an abridged procedure for clinical trial applications by relying on other regulatory authorities. FDA is running a consultation about its draft guidelines on the proposal for regulatory reliance on the conduct of clinical trials in the Philippines.   It is now more than two years since FDA streamlined its clinical trial regulations. Having made the changes, FDA looked to the World Health Organizatio...
  • ReconRecon

    Recon: Pfizer’s ulcerative colitis drug hits endpoints in Phase 3 trials; India’s Serum Institute plans new Africa plant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. health officials releasing some Jynneos vaccine doses for monkeypox -CDC ( Reuters ) Pfizer ulcerative colitis drug leads to remission in a third of patients -study ( Reuters ) Lilly's mirikizumab, once a contender for psoriasis, bolsters case for UC indication in maintenance trial data readout ( Endpoints ) Moderna testing potential monkeypox vaccines ( ...
  • Regulatory NewsRegulatory News

    FDA takes steps to relax blood donor requirements

    The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to receive blood while not significantly increasing risk to donors and patients.   On 23 May, the Center for Biologics Evaluation and Research published two draft guidances titled Compliance Policy Regarding Blood and Blood Component Do...
  • Regulatory NewsRegulatory News

    MDCG guidance aims to help manufacturers implement UDIs under MDR and IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a   question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).   The 14-page document covers 25 questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for systems and procedures packs and configurable devices, a...
  • Feature ArticlesFeature Articles

    FDA guidances for medical device regulation after enforcement discretion and EUA expiration

    This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires. These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended. The author suggests this limited oversight of the manufacture of ...
  • Regulatory NewsRegulatory News

    Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation

    Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a new formulation, while other factors like clinical effectiveness were not predictive of reformulation, according to a recent study published in JAMA Health Forum .   “This study reinforces concerns that manufacturers are using evergreening strategies to maintain revenue and avoid generic competition,” Ravi Gupt...
  • ReconRecon

    Recon: Pfizer, BioNTech seek vaccine EUA for children under 5; EU authorizes AstraZeneca COVID booster

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5 ( STAT ) ( Reuters ) White House sees decision on Moderna COVID shot for kids under 5 in next few weeks ( Reuters ) U.S. FDA sets June meeting dates for Moderna, Pfizer small children COVID-19 vaccines ( Reuters ) AbbVie asks FDA to approve Parkinson’s treatment ( BioPharmaDive ) Vir...
  • This Week at FDAThis Week at FDA
    Regulatory NewsRegulatory News

    This Week at FDA: House advances user fee bill, FDA’s enterprise modernization ambitions, and another 510(k) pilot

    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. It was a busy week for FDA on the Hill again, with FDA Commissioner Robert Califf testifying before the House Appropriations committee on Thursday and the House Energy & Commerce committee voting unanimously to send FDA user fee and reform legislation to the House floor.   On Thursday...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocilizumab), Paxlovid (ni...
  • Regulatory NewsRegulatory News

    FDA asks manufacturers to develop risk management plans to avert shortages

    The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also recommends risk factors to consider when developing the content of the RMPs.     Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), FDA was given new authorities to collect information from manufacturers in respond...