user fee – Talk Bio

FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

3 weeks ago talkbio0Tagged bioequivalence, Data Fidelity, GDUFA IV, Manufacturing, Metric (substance), onshoring, Performance, public health medicine (field), United States Food and Drug Administration, user fee

FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics

RFK Jr.’s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters

8 months ago talkbio0Tagged Does speak, Drug Industry, Fees, HHS, Mediation, negotiators, Staff, United States Food and Drug Administration, user fee

United States Food and Drug Administration, Does speak, Staff, negotiators, HHS, Mediation, user fee, Fees, Drug Industry

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

8 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