Prevision Policy Clips | RFK Warns FDA: “Preserve Your Records” And “Pack Your Bags,”

Prevision Policy Clips | Methodological Challenges To Patient Experience Data: FDA Workshop Dec. 13

Rare Disease Reviews At FDA: Support For “Outside The Box” Thinking By Agency Showcased At NORD Meeting

IRA “Small Biotech” Exemption Expansion Is On GOP Post-Election Wish List; PRV Reauthorization “Challenging Enough” Without Revisions

Prevision Policy Clips | OCE’s Pazdur Celebrates 25 Years At FDA – But He’s Not Thinking Of Retirement: “I’m Just Beginning Here"

Prevision Policy Clips | RSV Vaccines For Use In Children: FDA Vaccines Committee Will Discuss

Prevision Policy Clips | CDER Prioritizing Regulatory Flexibility Under Rare Disease Program: Cross-Cutting Internal Teams

FDA Antiemetic Draft Guidance May “Facilitate” Registrational Trials For Drugs Used Off-Label For Postoperative Nausea/Vomiting Prophylaxis, Agency Says

OTC Contraceptive Coverage Policy Could Expand To Smoking Cessation Products – If Proposed Rule Carries Forward After Election Day

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