FDA PreCheck Domestic Manufacturing Initiative Gets Positive Feedback From Industry With Focus On Pre-Approval Inspections

FDA Reiterates Cautious, Iterative Approach To Novel Cancer Endpoints; Added Development Time Helps Build Buy-In From Clinical Community

Prevision Policy Clips | FDA To Consider Narrowed Indication Under “Expedited Re-Review” Of Vanda's Hetlioz For Jet Lag

FDA Rx User Fee Carryovers Are About $450 Million At Start Of Shutdown, Financial Report Indicates

Price Negotiation Year Three: CMS Final Guidance Drops Threat To SubQ Biologic Formulations For Now; Keytruda, Opdivo Exempt Under New Orphan Drug Language

Insmed Brinsupri Pricing “Overreach” Criticized By ICER Panel; First Non-CF Bronchiectasis Treatment Hailed As “Game Changer,” But $60,000 Annual Price Draws Rebukes

Prevision Policy Clips | Shutdown Begins: FDA Publicly Affirms All Critical Safety Activities Will Continue

Pfizer/Trump Drug Pricing Deal Suggests Template For Industry: MFN Price For Medicaid, Promise US Gets Lowest Launch Prices Going Forward; Details Remain Vague

Advisory Committee Tracker: VRBPAC Comes Back, But Product-Focused Advisory Committees Have Vanished

Prevision Policy Clips | CDER Director Tidmarsh Questions Aurinia Lupus Drug Lupkynis In LinkedIn Post About Surrogate Endpoints

FDA Shutdown Plan: Agency Would Keep 86% Of Post-RIF Workforce, Contingency Plan Says; NDA, BLA Reviews Continue, But New Filings Would Be Held Up

RWE In Regulatory Decision-Making: Engaged FDA Review Division, Hard Outcomes And Strong Registries Are Themes; Don’t Come To Us After A Failed Trial, Agency Says

Prevision Policy Clips | FDA Will Retain 86% Of Post-RIF Workforce In Shutdown

Connecting COAs To Clinical Meaningfulness Is Key: FDA PFDD Workshop Highlights Common Challenges In COA Development And Review

Prevision Policy Clips | CMS “Global Benchmark for Efficient Drug Pricing (GLOBE) Model” Proposed Rule Received

ARPA-H Launches Personalized Medicine Push: “THRIVE” Will Pursue Genetic Platforms Beyond AAV And CRISPR; “GIVE” Seeks Bedside Manufacturing For RNA Therapies

Cell & Gene Therapies Post-Approval Surveillance: FDA Highlights Registries, Decentralized Data Collection Over Other RWD Sources For Long-Term Follow-Up

Prevision Policy Clips | Dana-Farber’s Anthony Letai Expected To Be Named NCI Director

FDA Regenerative Medicine Expedited Programs Guidance Update Emphasizes QC, CMC Issues; Adds Thinking On Preliminary Clinical Evidence, Real-World Evidence

FDA’s Updated COA Dossier: Agency Expects Reduction In Information Requests, Faster Reviews; Drug Sponsors Are Cautiously Optimistic

Cell/Gene Therapy Innovative Trial Designs Include Using Patients As Their Own Control; One Of Six Options Recommended In FDA Draft Guidance

FDA Hiring Is Recovering, But Pace Is Not Back To Pre-RIF Levels, Agency HR Leaders Say; Centralized Model Will Benefit Agency In Long Run, They Maintain

Prevision Policy Clips | Innovative Trial Designs For Small Population Cell And Gene Therapies: FDA Draft Guidance

Prevision Policy Clips | Scholar Rock’s SMA Therapy Apitegromab Receives FDA CRL Due To Manufacturing Issues

FDA Safety Labeling Changes Guidance Update Adds “Reduced Effectiveness” As An Adverse Effect; New Draft Will Replace 2013 Final Guidance