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  • Regulatory NewsRegulatory News

    FDA works to advance real-world data collection in pregnancy and lactation

    The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and lactation.   Despite the widespread use of prescription and over-the-counter medications by pregnant and lactating women, there is often little or incomplete information to guide decisions about starting and stopping medications or changing doses.   “Although the lack of s...
  • Regulatory NewsRegulatory News

    IVDR: Commission adds risk management standard to harmonized standards list

    The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The Commission has now officially added the international risk management standard EN ISO 14971:2019 to its reference list, as well as an amendment to the standard, EN ISO 14971:2019/A11:2021.   In total, the Commission has recogniz...
  • ReconRecon

    Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA’s RWE pilot cites challenges in emulating RCTs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Eli Lilly's treatment for type 2 diabetes ( Reuters ) ( Endpoints ) ( STAT ) FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE ( The Pink Sheet ) ( Endpoints ) Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs ( The Pink Sheet ) Unpersuaded by the data, FDA rejects cheap, ge...
  • This Week at FDAThis Week at FDA
    Regulatory NewsRegulatory News

    This Week at FDA: House holds user fee markup, CDER’s ARC for rare diseases

    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, we saw legislation to reauthorize the FDA’s user fee programs advance in the House. We also learned that FDA is standing up a new program to speed the development of treatments for rare diseases with unmet medical need. Plus, we take a look at a new GAO report on FDA’s efforts ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event

    RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years. Euro Convergence is the premier annual event for European regulatory professionals. This year’s event drew more than 500 participants from six continents and 33 countries. Attendees gathered for three days of education sessions, expert presentations and panel discussions curated exclusively by European regulato...
  • RoundupsRoundups

    Euro Roundup: EMA updates annexes on procedures for running GCP inspections

    The European Medicines Agency (EMA) has updated a set of 15-year-old annexes about the procedures for conducting good clinical practice (GCP) inspections requested by the Committee for Medicinal Products for Human Use (CHMP).   EMA published the five annexes in 2007. Since then, the regulatory landscape has changed, most notably through the adoption and recent implementation of the Clinical Trial Regulation (CTR). Many of the new additions to the annexes relate to CTR,...
  • ReconRecon

    Recon: Moderna completes EUA submission for younger kids and adolescents; Generic firms to cap price of Paxlovid copies at $25 in low-income countries

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden marks 1 million Americans dead from COVID ( Reuters ) Moderna completes FDA submission for use of COVID shot in adolescents, kids ( Reuters ) Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11 ( NYTimes ) Lawmakers wade into a contentious battle over orphan drug monopolies ( STAT ) Is Paxlovid, the Covid pill, reaching those who most ne...
  • Regulatory NewsRegulatory News

    Euro Convergence: Attendees want end to regulatory ‘micromanagement’

    Corrected 13 May 2022* AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authorities: Trust us.   Gathered at RAPS Euro Convergence at a panel on how to better communicate with health authorities and notified bodies, they voiced their displeasure and asked for a respite from what they describe as micromanagement.   “You heard from academia, you heard from the early start-ups, you heard from the large manufacturers [at this confe...
  • Regulatory NewsRegulatory News

    Pandemic highlighted challenges of ATMP clinical trials in Europe

    AMSTERDAM - A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19 pandemic, Charlie Mortazavi said here at RAPS Euro Convergence.   That attention and future clarification of the regulations could help clear the way for clinical trials of advanced therapy medicinal products (ATMP) in Europe, said Mortazavi, senior manager of global regulatory affairs a...
  • RoundupsRoundups

    FDA Approvals Roundup: Olumiant, Enhertu

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Olumiant use extended for hospitalized COVID-19 patients needing oxygen support Eli Lilly’s Olumiant (baricitinib tablets ) has been granted a new indication for treating COVID-19 in hospitalized adults who require varying degrees of ventilation/oxygen support.   Olumiant has been available to treat COVID-19 in the US under emergency use ...
  • Regulatory NewsRegulatory News

    FDA offers insight into product quality assessment principles

    The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications (NDA), biologics license applications (BLAs), and supplements.   The draft guidance , released on 10 May, provides details on possible mitigation strategies for quality issues and the circumstances under which unresolved quality issues could be addressed during a public health emergency or wides...
  • ReconRecon

    Recon: Teva, Allergan willing to pay $5B to settle opioid suits; FTC tells Medtronic to divest Fiagon in Intersect takeover

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's $11.6 bln Biohaven buy could spark more biotech deals ( Reuters ) Arkansas sues drugmakers, pharmacy benefit managers over insulin costs ( Reuters ) Moderna CFO exits a day after taking charge as former employer launches probe ( Reuters ) J&J appoints consumer health head Thibaut Mongon to CEO of spun-off business ( Reuters ) Teva, Allergan Willing t...