FDA CMC Readiness Pilot: Sponsors Report Positive Experiences Despite Limited Early Uptake

Prevision Policy Clips | AZ’s FluMist DTC Ad Draws Cease-And-Desist Letter Signed By CBER Director Prasad

MAHA Strategy Includes Drug Approval “Improvements”; Pediatric Cancer Treatment Plans Are AI Test Cases, While NIH Would Take RWD Platform Lead

Prevision Policy Clips | “Hybrid” Pre-Approval Inspections Final Guidance Provides Clarification On Timelines

Non-Opioid Analgesics For Chronic Pain: Broad Label Could Be Supported By Combining Condition-Specific Indications, FDA Guidance Suggests

Prevision Policy Clips | Non-Opioid Chronic Pain Guidance Recommendations Include Superiority Trial Designs

HHS Seeks To Close Down DTC Ads By Strengthening Disclosure Rules: FDA Starts Campaign With Broad “Notice” Letters And 100 “Cease And Desist” Warnings

Preserving Placebos In Rare Disease Trials: FDA Showcases Flexibility During First “RISE” Meeting – But Makes Case That Placebo Controls Still Have A Place

Prevision Policy Clips | Former CBER OTP Deputy Director Rachel Anatol Joins Lilly

Prevision Policy Clips | Compounded GLP-1 Imports: FDA Launches “Green List”

Kennedy’s Vaccine Policies Face Bipartisan Pushback During Senate Hearing; Legacy Of “Operation Warp Speed” Could Be Vulnerability For HHS Secretary

Prevision Policy Clips | Senate Finance Committee Advances HHS General Counsel Nominee

“Real-Time” CRLs Are Here, As FDA Releases 34 Rejection Letters From 2025: Sponsors Will Need To Adjust Communication Plans; Replimune, Ultragenyx Letters Show Nuances

Prevision Policy Clips | Artificial Intelligence At FDA: E&C Health Ranking Member DeGette Calls For More Funding, Protocols

FDA “Plausible Mechanism” Pathway Will Be Limited To “Bespoke” Treatments, Prasad Tells Inaugural “RISE” Meeting; Harmonizing Toward CDER’s Historic Posture On Rare Disease?

FDA Launching Single-Trial Pathway For In-Born Error Treatments, Called “RDEP”; Sponsors, Agency Will Agree Up-Front On “Supportive Evidence” Plan

Prevision Policy Clips | HHS Touts "Real Time" Drug Price Information For Prescribers Under Final Rule

FDA Deadline Tracker: Path To 60 NME Approvals Looks Steep; Two Rejected, One Delayed In August; Only Four On September Calendar

Prevision Policy Clips | NIH Funding Would Be Flat Under House Appropriations Bill

FDA Proposes “Product-Agnostic” External Control For Rare Pediatric Brain Tumor DMG/DIPG As Potential Model For Other Oncology Registries

Prevision Policy Clips | CDC Acting Director Will Be HHS Deputy O’Neill

COVID Vaccine Updates: Sponsors Agree To Study Possible Link Between Vaccination And Long COVID Following Strain Update; CBER’s Prasad Suggests Goal Is Reassurance

Oncology Registries: FDA Eager To See Field Advance; August Workshop Is “Kick Off” For Longer Process

Prevision Policy Clips | CDC Leadership In Turmoil: HHS, White House Say CDC Director Monarez Has Been Fired

Prevision Policy Clips | FDA Neuroscience Office Changes: Laura Jawidzik Is Leading Division Of Neurology 2