public health medicine (field)

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

2 months 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

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

Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction

4 months ago talkbio0Tagged Biological Science Disciplines, Canal Row Advisors, innovation, Leadership, Michael Rogers, Policy, public health medicine (field), reform, regulatory consulting, regulatory strategy, United States Food and Drug Administration

Canal Row Advisors; FDA leadership; regulatory consulting; Michael Rogers; Hilary Marston; life sciences; regulatory strategy; public health; FDA reform; innovation policy

US Government Shutdown Threatens to Stress an Already Depleted FDA

4 months ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time

5 months ago talkbio0Tagged Application procedure, drug applications, openFDA, public health medicine (field), radical transparency, real-time disclosure, regulatory transparency, Response Letters, United States Food and Drug Administration

FDA; complete response letters; real-time disclosure; drug applications; radical transparency; pending applications; regulatory transparency; public health; openFDA

Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform

5 months ago talkbio0Tagged childhood health, childhood vaccine schedule, Chronic disease, Commission, federal directives, Food Policy, MAHA, Prescription Drug Overuse, public health medicine (field), Robert F. Kennedy Jr., Vaccine Reform

MAHA Commission; chronic disease; vaccine reform; Robert F. Kennedy Jr.; childhood health; food policy; medication overuse; public health; federal directives; childhood vaccine schedule