Prevision Policy Clips | BIO Makes Leadership Change: Former GlycoMimetics CEO Rachel King Named Interim Head

Prevision Policy Clips | CDER Emphasizes Case For Makena Withdrawal In Briefing Document

Gene Therapy And Accelerated Approval: Skysona Review Memo Suggests Bluebird Experience Is Important Precedent – But Not Easy To Follow

Prevision Policy Clips | GDUFA III Guidances Continue To Roll Out: FDA Updates Competitive Generics, Post CRL Teleconference Guidances

MedPAC Focus On Part D Going Forward: Keeping A Close Eye On Rebates As Inflation Reduction Act Is Implemented

The New User Fees: NDA/ANDA Filing Fees Grow Modestly In FY 2023, But Biosimilar Fees Stay Flat

Prevision Policy Clips | Cardio-Renal Advisory Committee To Meet Dec. 13-14 To Review Cytokinetics Heart Failure Drug, Viatris’ Pediatric Revatio

CBER Office Of Therapeutic Products Re-Org Takes Effect In February 2023; Hiring For New Positions Is Underway

Prevision Policy Clips | CBER Office Of Therapeutic Products Will Go Into Effect Mid-February 2023; Hiring For New Positions Is Underway

GDUFA III Kicks Off: FDA Quickly Issues Process Guidances On New Approaches For NDAs With Facilities Unready for Inspection And DMF Prior Assessments

FDA Establishes STAR Real Time Review, Rare Disease Endpoint Development Pilots Under PDUFA VII

Advisory Committee Tracker: OTC Oral Contraceptive NDA Will Put FDA Committees Back In Political Spotlight; ODAC To Consider Another Withdrawal

Prevision Policy Clips | FDA Hits The Ground Running With User Fees Finally Secure: STAR, RDEA Pilots Announced

HHS IG Accelerated Approval Report Finds One-Third Of Confirmatory Trials Delayed; Estimate Of Federal Spending Impact Appears Overstated

Prevision Policy Clips | Amylyx Relyvio (AMX0035) Approved For ALS: “Substantial Evidence” Found In Single Positive Trial

FDA Proposes Changes To Informed Consent As Part Of “Common Rule”-Related Update To IRB Regs; Ongoing Studies Will Be Grandfathered

Prevision Policy Clips | Sarepta DMD Gene Therapy BLA Filed: Testing Accelerated Approval Path

Prevision Policy Clips | Medicare Part B Premiums Decline For 2023, Thanks To Aduhelm Fizzle

OGD In Transition Heading Into GDUFA III: FDA Veteran Rosencrance Will Be Interim Head Following Director Choe’s Departure

FDA Gene Therapy User Fee Boost Is Well Timed, But Staff Crunch May Linger: New “Super-Office” Status Could Help With Hiring

FDA User Fee Reauthorization Secured, But Continuing Resolution Sets Up Lively “Lame Duck” Session In December: Which (If Any) Policy Riders Will Make The Cut?

Rebiotix/Ferring Rebyota Clears Advisory Committee For CDiff: Milestone Event For Live Therapeutics Class But FMT May Be Special Situation

Prevision Policy Clips | FDA User Fee Funding Secure, But CR Sets Up Eventful “Lame Duck” Session

Pediatric Ethical Considerations Guidance Outlines “Prospect of Direct Benefit” And “Minimal Risk" Criteria

OTAT’s Bryan Offers Broad Framework For Accelerated Approval For Gene Therapies: Biomarker + Evidence Of “Clinical Effect”