Regulation or Law – Page 2

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

3 months 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

FDA Acting CDER Head Jacqueline Corrigan-Curay to Retire Amid Leadership Turnover

3 months ago talkbio0Tagged agency departures, CDER, Drug Regulations, Jacqueline Corrigan-Curay, Leadership, Personnel Turnover, Retirement, United States Food and Drug Administration

FDA; Jacqueline Corrigan-Curay; CDER; retirement; leadership turnover; drug regulation; agency departures

Trump Administration Considers Limits on Direct-to-Consumer Drug Advertising

3 months ago talkbio0Tagged Ditiocarb, drug price, executive order, Health Policy, Pharma, pharmaceutical regulation, Transplant Registry Unified Management Program

Trump administration; DTC drug advertising; pharmaceutical regulation; drug pricing; executive order; health policy; pharma marketing

New Rules and Regulatory Trends in Biopharma Manufacturing in 2025

3 months 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

Trump Taps Dr. Oz as Lead Negotiator for ‘Most Favored Nation’ Drug Pricing Policy

4 months ago talkbio0Tagged Dr., Drug Costs, drug price, Health Policy, Myasthenic Syndromes, Congenital, Nation, ounce, pharmaceutical negotiations, Transplant Registry Unified Management Program

Trump; Dr. Mehmet Oz; Most Favored Nation; drug pricing; CMS; pharmaceutical negotiations; healthcare policy; drug costs

Roche could rethink $50B US expansion plan if new policies ‘harm’ operations

4 months ago talkbio0Tagged expansion, Infantile Neuroaxonal Dystrophy, Investments, Policy, Roche (company), United States

Roche (company), United States, Investments, expansion, Policy, Infantile Neuroaxonal Dystrophy

Accelerating Clinical Trial Excellence: A Seamless IRB & IBC Collaboration

4 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

Protect Your Trial Data: Endpoint, Imaging, and Safety Review

4 months ago talkbio0Tagged Biomechanical compliance, Clinical Trials, CTMS, Diagnostic Imaging, Encryption, End Point, General Data Protection Regulation, safety review, Security - service

Clinical Trials, Diagnostic Imaging, Security – service, End Point, safety review, General Data Protection Regulation, Biomechanical compliance, CTMS, Encryption

Leaked HHS budget signals $40B in cuts, assumes ACA subsidies expire

5 months ago talkbio0Tagged Administration occupational activities, Agencies, assumes, Budgets, HHS, Leaked, Patient Protection and Affordable Care Act, Programs - Publication Format, proposal - intent, Subsidies

Budgets, HHS, Patient Protection and Affordable Care Act, Subsidies, Agencies, Leaked, Administration occupational activities, proposal – intent, assumes, Programs – Publication Format

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

5 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