Drug Approval – Talk Bio

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

2 weeks ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

FDA Policy Tracker: 2025 Was a Year of Change

3 weeks ago talkbio0Tagged 2025, Drug Approval, Food Safety, GRAS Reform, Improvements, Mental Recall, Trump administration, United States Food and Drug Administration

FDA; 2025; Trump Administration; Food Safety; FSMA 204; GRAS Reform; Drug Approvals; Recall Improvements

FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals

1 month ago talkbio0Tagged Drug Approval, early-phase trials, real-world data, real-world evidence, Real-world Evidence, RWE, Transplant Registry Unified Management Program, Trump, United States Food and Drug Administration

FDA; real-world data; real-world evidence; RWE; early-phase trials; drug approval; Marty Makary; Trump

FDA Breakthrough Designations Lead to Priority Reviews, Report Finds

2 months ago talkbio0Tagged biotechnology innovation, Breakthrough Therapy, CDER, Drug Approval, expedited pathway, Identifier, Infrequent, Neoplasms, Priority Review, regulatory science, United States Food and Drug Administration

FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

2 months ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

2 months ago talkbio0Tagged Center for Drug Evaluation, Center for Drug Evaluation and Research, Drug Approval, George Tidmarsh, leadership instability, OCE, Oncology Center of Excellence, Project, regulatory reform, research, review delays, Richard Pazdur, United States Food and Drug Administration

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

2 months ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis