CIOMS Draft Report Proposes Best Practices for Implementing AI Tools and Processes in Pharmacovigilance
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Risk Factors Associated With Late-Onset Epilepsy in Dementia and Mild Cognitive Impairment
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Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
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FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
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FDA Advisory Committee Votes Favorably that the Data Support Arimoclomol as Effective Treatment for Patients with Niemann-Pick Disease Type C | Zevra Therapeutics, Inc.
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EMA has launched a new page, “Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing.“
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FDA Commissioner Marty Makary Chooses Vinay Prasad from UCSF to lead CDER
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AMWA’s Introductory Guide to Regulatory Writing
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Missing REMS Delays Cytokinetics' heart drug Aficamten's PDUFA Date by 3 Months
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EndPoints News: After FDA firings, drug reviewers are asked to volunteer for administrative work
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Updated SPIRIT 2025 Checklist for Developing More Comprehensive and Complete Clinical Trial Protocols, Published in JAMA
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Evaluation of United Kingdom (UK)—Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines Regulation
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Novavax Covid-19 Vaccine BLA Review by the FDA: Is Imposition of an Onerous Postmarketing Commitment a way to Stall Approval
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My Experience with Medical/Regulatory Writing Position Job Search and What I Learned About the Current Job Market in the US
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Potential Expiration or Sunsetting of the FDA’s Pediatric Priority Review Voucher Program
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The Shingles Vaccine and Reduction of Dementia
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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
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China’s biotech market is staging a comeback that US biotech can only wish for
News about any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. | Or we can talk about career advice. Whatever.
Robert Califf's Second Act: Substack - Califf's Commentary
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FDA Commissioner Makary Proposes a Mechanism-based Conditional Approval Approach to Ultra-rare Diseases
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Update on the PMDA Pediatric Requirement: Sponsors are Now Obligated to Prepare a Pediatric Drug Development Plan and Initiate Studies Including Japanese Children
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Upcoming Conference: Mathematics of Neuroscience and AI
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FYI - FDA has postponed the "Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act" originally scheduled for 15 May
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The Real-life Impact of FDA RIFs: The Story of Karen Hollitt, an Air Force Veteran and Former Employee at FDA’s Office of Pharmaceutical Quality
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NICE recommends cladribine for treating active relapsing forms of multiple sclerosis
Multiple Sclerosis related literature including peer-reviewed scientific research, resources, news, and articles only from authentic sources such as MS societies, professional groups and websites, and mainstream news orgs (eg, NYT). ~~~> Welcome and join the subreddit to follow and comment.
