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  • ReconRecon

    Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing deal with RQ Bio

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA clears Covid booster shot for healthy kids ages 5 to 11 ( STAT ) ( Reuters ) ( FDA ) U.S. to allow baby formula imports amid nationwide shortage ( Reuters ) ( FDA ) Abbott, FDA reach agreement to reopen baby formula facility in Michigan ( Reuters ) ( FDA ) Baby formula makers ramp up U.S. supplies to tackle shortage ( Reuters ) U.S. Democrats unveil bill ...
  • Regulatory NewsRegulatory News

    Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints

    More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by a single pivotal trial, and slightly less than half of pivotal trials supporting novel drug approval used surrogate endpoints as a primary outcome, according to new research published in JAMA Network Open .   The use of fewer pivotal trials and acceptance of surrogate endpoints is the continuation of a trend with the development of new regulatory pathways ...
  • 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 ...