Pre-Diversity Action Plan? OCE’s Pazdur Urges Attention To Phase 1/2 Enrollment To Tease Out PK Differences; Sponsors Stress Challenge Of Meeting US Goals In Global Trials

Prevision Policy Clips | OTC Oral Contraceptive Coverage Proposed Rule Would Also Broaden Rx Coverage Mandate

Accelerated Approval In Oncology: 15% Withdrawal Rate, But A Failed Confirmatory Trial “Does Not Always Equate To A Failed Drug,” FDA Says

Prevision Policy Clips | Gilead To Withdraw Accelerated Approval For Trodelvy In Urothelial Cancer

Rare Disease Hub Top Priority Should Be Consistent Review Standards, Stakeholders Tell FDA; CBER’s Marks Explains Why Full Center Of Excellence Not Pursued

Prevision Policy Clips | Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development Final Guidance Includes Modest Changes

FDA On Oncology R&D Trends: Patient Registries As External Controls Not Yet Ready For “Prime Time”; FDA Is “Thinking Very Deeply” About “Digital Twins”

Prevision Policy Clips | FDA Rare Disease Endpoint Advancement Pilot Has Two Participants

Oncology Drug Reproductive Toxicity: FDA Guidance On Ovarian Toxicity Monitoring Coming Soon; FDA/ASCO Urge Collection Of Serum Biomarker And Clinical Measures During Workshop

Prevision Policy Clips | Lilly Tirzepatide “Shortage” Status Now Uncertain? FDA Backs Down

CBO Drug Pricing Options: International Reference Pricing Would Have “Large Effect,” But Expanding IRA Would Not; Report Raises Questions About “March-In” Approach

The Ultra Rare Effect: Stealth Bio’s Elamipretide For Barth Syndrome Wins Split Vote From Cardio-Renal Advisory Committee Despite Thin Evidence Of Efficacy

Prevision Policy Clips | FDA 15-year Follow-Up For Gene Therapies Challenged As “Mind Boggling”

Pandemic Influenza Preparedness: H5 Strain Updates Will Begin In “Inter-Pandemic” Period; VRBPAC Eager For mRNA Options, But Current Focus Is On Approved Products

Prevision Policy Clips | Trump Backing Off Of Most Favored Nation Rule? PhRMA CEO Ubl Says PBM Reform

CMS Announces “Sample” Drug List For $2 Generics Model: 2027 Is Earliest Possible Start Date

Medicare Coverage Of Weight Loss Drugs: CBO Sees Slim Offsetting Savings From Use In Obese/Overweight Population; 10-Year Federal Cost Pegged At $35 Billion

Prevision Policy Clips | Medicare Coverage Of Obesity Agents Would Cost $35 Billion Through 2034, CBO Estimates

Stealth Bio Elamipretide For Barth Syndrome: Advisory Committee Is Last Chance To Head Off Rejection; FDA Says Data Do Not Support Efficacy

Re-Scoring The IRA: Part D Overhaul Costs Are Higher Than CBO Projected For 2025 – More Than Offsetting Higher-Than-Projected Price Negotiation Savings

Prevision Policy Clips | Hurricane Helene Underscores FDA Shortage Messages: Commissioner Califf

Prevision Policy Clips | Maximum Fair Price Based On Ex-US Pricing Would Reduce Rx Drug Prices By 5% “And Possibly Substantially More,” CBO Says

Rare Disease Project Proliferation At FDA: Agency Needs To Focus On Management Of Initiatives, National Academy Of Medicine Report Says

Prevision Policy Clips | FDA Women’s Health Research Roadmap

Price Negotiation Year Two: CMS Revamps Patient Input Process In Final Guidance, But Leaves Key Policies Unchanged, Including Hands-Off Approach To 340B