regulatory – Talk Bio

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

6 days ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

3 weeks ago talkbio0Tagged Biopharma, country-of-origin labeling, digital quality systems, forced labor compliance, green manufacturing, import rules, Manufacturing, regulatory, Serialization, Trump administration tariffs, United States Food and Drug Administration

biopharma manufacturing; 2025 regulations; FDA; digital quality systems; green manufacturing; import rules; Trump administration tariffs; country-of-origin labeling; forced labor compliance; serialization

Accelerating Clinical Trial Excellence: A Seamless IRB & IBC Collaboration

2 months ago talkbio0Tagged Biosafety, Clinical Trials, Collaboration, Efficiency, Ethics Committees, Research, Homo sapiens, IBC, multi-institutional research, regulatory, research, streamlined review

Clinical trials, IRB, IBC, collaboration, streamlined review, multi-institutional research, regulatory efficiency, research acceleration, biosafety, human subject protection

U.S. Biotechs Reveal Tariff Exposure as Trade Inquiry Signals Imminent Pharmaceutical Tariffs

3 months ago talkbio0Tagged Evaluation, global supply chain, Impact food supplement, Import, Manufacturing, pharmaceutical ingredients, pharmaceutical tariffs, Policy, regulatory, reshoring, Sectioning technique, supply chain exposure, TNFRSF19 gene, United States

U.S. biotech, pharmaceutical tariffs, Section 232 investigation, supply chain exposure, trade policy, import costs, reshoring manufacturing, drug pricing, global supply chain, pharmaceutical ingredients, regulatory impact

Navigating the Biotech Winter: Strategies for Survival and Growth Amid Ongoing Industry Downturn

3 months ago talkbio0Tagged Acquisitions, adaptation, Artificial Intelligence, biotech downturn, growth opportunities, innovation, Landscapes, layoff, Precision Medicine, regulatory, strategic, Survival, trends qualifier

biotech downturn, layoff trends, funding challenges, strategic adaptation, innovation, mergers & acquisitions, workforce planning, precision medicine, artificial intelligence, regulatory landscape, survival strategies, growth opportunities

Biopharma Layoff Trends in Q1 2025 and Outlook for Q2

3 months ago talkbio0Tagged Biopharma, Biopharma layoffs, Changing, Industry, Legal patent, Pharma, pharmaceutical employment, Q1 2025, Q2 layoff, regulatory, restructuring

Biopharma layoffs, Q1 2025 layoffs, biotech job cuts, pharma workforce reductions, restructuring, patent cliffs, regulatory challenges, Q2 layoff forecast, pharmaceutical employment trends, biopharma industry changes.

Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs

3 months ago talkbio0Tagged Biopharma regulatory issues, Budgets, delays, drug review, HHS layoffs, layoffs, Medical Devices, operational, PDUFA, regulatory, RFK Jr., United States Food and Drug Administration, user fee

FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions