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”

ODAC Votes Secura’s Duvelisib Has Unfavorable Benefit-Risk Profile As FDA Sets Stage For Withdrawal; OCE’s Pazdur Silent, Gormley Takes Lead

Prevision Policy Clips | RMAT Designation Success Rate Is 37% For Cell/Gene Therapies, CBER/OTAT Director Wilson Bryan Says

ODAC Votes Down Spectrum Poziotinib For Rare NSCLC Subtype; Efficacy And Safety May Be Acceptable, But FDA Dosing, Confirmatory Trial Concerns Prevail

Prevision Policy Clips | User Fee Deal Reached For A Clean Five-Year Reauthorization To Be Attached To Continuing Resolution

OncoPeptides Pepaxto Withdrawal Endorsed By FDA Committee, But Sponsor Seems Likely To Resist; Pomalyst Caught In The Crossfire?

ICER Obesity Class Review Could Impact Potential Changes To Coverage Rules, Advocates Say; Panel Does Not See Novo’s Wegovy As Cost Effective

Prevision Policy Clips | Accelerated Approval “On-Ramp”/“Off-Ramp” Strategies, “Uncertain Relationship” Of Response Rate To Survival

CREATES Act Path For Obtaining Brand Samples Outlined In FDA Draft Guidance; “Covered Product Authorization” Replaces “Safety Determination Letter”

Bluebird Opens AA Pathway For Gene Therapies With Skysona CALD Approval; FDA Appears To Have Pushed Accelerated Route