• Regulatory NewsRegulatory News

    Experts: MDR transition delay needs clarification, industry engagement to succeed

    Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the development of new guidances, according to experts who spoke to Focus . They also said that manufacturers need to take advantage of the extension and not wait till the last minute to submit their applications.   Over the past year, stakeholders have voiced grave concerns that the deadline for manufacturers to transition f...
  • Regulatory NewsRegulatory News

    CDER director calls for simplifying clinical trials to boost diversity

    Encouraging researchers and sponsors to simplify clinical trials and employ a fit-for-purpose protocol is one way that the US Food and Drug Administration (FDA) can promote recruitment of trial populations that are racially and ethnically diverse, according to Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER).   FDA has been focused on increasing clinical trial diversity, issuing draft guidance in April 2022 that calls on sponsors to de...
  • ReconRecon

    Recon: FDA’s increased use of clinical holds; BioNTech buys AI startup InstaDeep for up to $682M

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US U.S. experts recommend weight-loss drugs for obese children ( Reuters ) Abbvie raises sales outlook of two immunology drugs to more than $17.5 bln in 2025 ( Reuters ) Sen. Sanders asks Moderna not to hike COVID vaccine price ( Reuters ) ( STAT ) FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises” ( STAT ) FDA Increasingly Halting Hum...
  • RoundupsRoundups

    Asia-Pacific Roundup: Malaysia’s MDA shortens evaluation timelines for combination products

    Shorter evaluation timelines and new information on the registration process highlight the fifth edition of the Malaysia Medical Device Authority’s (MDA) guideline on combination products.   MDA uses two terms for combination products based on their primary mode of action. If the primary mode of action is not based on pharmacological, immunological or metabolic means, the authority calls the technology a medical device-drug combination product (MDDCP). The new evaluati...
  • Regulatory NewsRegulatory News

    Califf, past FDA chiefs look for partners to curb misinformation

    Past and present commissioners of the US Food and Drug Administration (FDA) say the agency needs partners in combatting public health misinformation, and industry, clinicians, patient advocates and academic leaders all have a role to play.   “Realistically, FDA needs help,” Mark McClellan, MD, PhD, who served as FDA Commissioner from 2002-2004, said at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory ...
  • Regulatory NewsRegulatory News

    Industry calls for flexibility in FDA’s pediatric measurement guidance

    A pharmaceutical trade group and several drugmakers urged the US Food and Drug Administration (FDA) to take a more flexible approach in its guidance on pediatric measurements in clinical trials and questioned whether 12 months is sufficient to provide meaningful information for growth and development.   These comments were made in response to the agency’s call for feedback on the draft guidance, which outlines ways sponsors can measure pediatric growth consistently in ...
  • ReconRecon

    Recon: Eisai seeks full approval for Alzheimer’s drug Leqembi; AstraZeneca buys Cincor Pharma for up to $1.8B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Supreme Court rebuffs Pfizer plan to help patients pay for heart medication ( Reuters ) ( Bloomberg ) FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate ( Endpoints ) Lundbeck and Otsuka win FDA priority review of Alzheimer’s agitation drug ( Medwatch ) Doctors inclined to prescribe new Alzheimer’s drug despite conce...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Eisai wins accelerated approval for Alzheimer’s drug Leqembi

    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. In major news this week, we saw FDA grant accelerated approval to Eisai's Alzheimer’s disease drug Leqembi (lecanemab-irmb). The agency also moved to enable retail pharmacies to dispense mifepristone by revising the shared risk evaluation and mitigation strategy (REMS) for Mifeprex and g...
  • Regulatory NewsRegulatory News

    Drugmakers, advocacy groups ask FDA to clarify expanded access draft guidance

    Pharmaceutical companies and research advocacy groups are asking the US Food and Drug Administration (FDA) to clarify some of the provisions of its recently updated expanded access draft guidance. Commenters inquired about the agency setting a response time frame for responding to expanded access waivers, when children qualify for expanded access drugs and expanded access to medical devices.   In November, FDA published the updated draft guidance for when investigation...
  • Regulatory NewsRegulatory News

    European Commission moves to delay MDR transition

    This article has been corrected to clarify information related to proposed removal of the sell-off date provisions. The European Commission on Friday adopted a proposal to allow medical device makers more time to certify their products under the EU Medical Devices Regulation (MDR) amid concerns that the regulation could prompt shortages of lifesaving products. The proposal would also repeal the “sell-off” date provision under both MDR and the In Vitro Diagnostic Medic...
  • Regulatory NewsRegulatory News

    Provider groups, researchers raise concerns about extrapolating adult data in children

    Clinicians and researchers are voicing concerns that the US Food and Drug Administration (FDA) has overemphasized the role for extrapolating adult data in pediatric populations as part of recent draft guidance on ethical considerations for conducting clinical trials that involve children.   In September 2022, FDA issued draft guidance aimed at assisting industry, sponsors and institutional review boards (IRBs) when conducting or reviewing clinical investigations of dru...
  • Regulatory NewsRegulatory News

    CDER approved 37 novel drugs in 2022, its lowest number since 2016

    After several years with high numbers of novel drug approvals, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 37 new drug therapies in 2022.   CDER’s 37 new drug approvals in 2022 represents the lowest number of novel drugs approved by the Center since 2016 . The Center approved 50 novel drugs in 2021 , 53 novel drugs in 2020 , 48 drugs in 2019 and 59 drugs in 2018 . (RELATED: FDA approved more first-in-class...