White House Budget Endorses “All-Interchangeable” Biosimilar Policy; FDA Seeks Modest Increase Despite Flat Funding In FY 2024

Early Alzheimer’s Drug Development Guidance Updated To Reflect FDA Expectations For Biomarker-Based Strategies—And Reality Of Accelerated Approvals

Prevision Policy Clips | Alzheimer’s Drug Development Draft Guidance Updated By FDA To Reflect “Current Thinking Regarding The Use Of Biomarkers"

FDA Promises Flexibility In Informed Consent Draft Guidance; Consults With Patient Advocacy Groups May Make Documents More Understandable

CMS Sickle Cell Gene Therapy Model RFA Includes ASP Waiver; PROs Among Four Outcome Metrics For Rebate Purposes Identified By CMMI

Prevision Policy Clips | Lilly’s Donanemab For Alzheimer’s Will Go To FDA Advisory Committee, Delaying Approvability Action

Complex Innovative Design Program Gets High Marks For “Informal” Collaboration With FDA, Agency Openness To External Controls

Prevision Policy Clips | Out-Of-Pocket Drug Spending Cap “For All” Is Big Positive For Biopharma, IRA Price Negotiation Expansion To “At Least” 50 Drugs Per Year Is Not

Janet Woodcock’s Exit Interview: Accelerated Approval “Differential Pricing” Models Could Encourage Confirmatory Trials, But Sponsors’ Financial Health Should Be Considered

Prevision Policy Clips | Lumicell’s Lumisight Breast Cancer Imaging Agent Clears FDA Advisory Committee With 16-2 Vote

Prevision Policy Clips | Vanda Hetlioz Jet Lag Indication Laid To Rest? FDA Denies Another Request

Prevision Policy Clips | LDT Final Rule Goes To OMB For Review On March 1

Gene-Edited Products: Drug Sponsors Should “Strongly Consider” Accelerated Approval, FDA Reviewers Say; Off-Target Safety Still A Concern

Orphan Drug Price Negotiation Fixes Remain A Partisan Issue During House Hearing; Democrats Also Raise Issues With Rare Disease PRV Reauthorization

RWE Efforts Need Better Data Standards And Quality – No Matter The Regulatory Intent, OCE’s Kluetz Says; Case Studies Show Even “Failed” Attempts Have Benefits

Prevision Policy Clips | Medicare Part D Co-Pay “Smoothing” Option Will Be Offered To Any Beneficiary With Co-Pay Of $600

“Point/Counterpoint” Joint Advisory Committee Documents Will Remain The Norm For ODAC, But Not For Other CDER Committees

Advisory Committee Tracker: Agenda Still Sparse As FDA Prepares For In-Person Meetings To Return This Fall

Prevision Policy Clips | FDA Informed Consent “Key Information” Draft Guidance Includes Template

“We’re Coming Back”: Most Advisory Committees Will Be In-Person This Fall; Changes In Recruitment Are Underway – But The Votes Will Stay

FDA’s Gene/Cell Therapy Office Ramp Up Will Take 2-3 Years, CBER’s Marks Predicts; Will 2027 Be A Milestone Year For Rare Disease Organization At FDA?

Prevision Policy Clips | Manufacturing User Fees Floated By Woodcock To Better Fund Inspections

Pepaxto Withdrawal Indicates FDORA Has Improved The Process For Pulling Accelerated Approval – But Not Solved All FDA’s Problems

Prevision Policy Clips | CMMI Will Issue Further Details, Requests For Applications For Cell/Gene Therapy Access Model “Very Soon”

Prevision Policy Clips | Office Of Therapeutic Products “75%-80%” Staffed, CBER Director Peter Marks Says