Gene Therapy Dosing Limits To Be Discussed By FDA Advisory Committee; Toxicity Review Likely Aimed At Public Education Rather Than Immediate Changes

BLA Approval Of Pfizer/BioNTech COVID-19 (Comirnaty) Vaccine Includes Six Postmarket Requirements On Myocarditis/Pericarditis

PDUFA VII Agreement Gives FDA $100 Million Raise For FY 23, Funds 352 New FTEs Over Five Years: Cell/Gene Therapy Reviews, Bioinformatics Support Will Benefit

Prevision Policy Clips | PDUFA VII: FDA/Industry User Fee Agreement Includes New PMR Review Goals, Tests Broader “Real Time” Review

Prevision Policy Clips | FDA Anti-Infectives Division Director Nambiar Departs After 9 Years

Prevision Policy Clips | COVID-19 Vaccine Boosters Ready For General Population Week Of September 20, President Biden

Prevision Policy Clips | President Biden Expected To Discuss COVID-19 Booster Shots In White House Remarks Today

Part B Discarded Dose Rebate Would Kick In Jan. 1, 2023 Under Bipartisan Infrastructure Bill; New Drugs Exempt For 18 Months, HHS Could Set More Exceptions Via Rulemaking

Prevision Policy Clips | COVID-19 Vaccine Boosters On ACIP Agenda August 24; Pfizer/BioNTech Could Be Up For A Vote

ACIP Readies For COVID Vaccine Boosters: Policy Framework Suggests Same Priority Order As Original Doses – Once FDA Signs Off

Prevision Policy Clips | OCHEN Deputy Mary Thanh Hai Likely to Head Office Following Ellis Unger’s Retirement From FDA

“Intended Use” Final Rule Maintains Defense Of FDA’s Broad Authority Over “Off Label” Promotion, No Safe Harbor For Scientific Exchange

Biden Speech Encouraging Congress On Drug Pricing Solutions Tees Up Senate Finance Focused Negotiation Plan As Positive, Narrower Approach

Prevision Policy Clips | PDUFA Fee Rates For FY 2022: $3.117 Million For Applications Requiring Clinical Data

Prevision Policy Clips | Biden Drug Pricing Intro “Vision” Statement Leads With Medicare Negotiation

ICER Atopic Dermatitis: JAK Safety Delays, Rebate Issues Are Key Topics Of Discussion; Comparative Efficacy Vs. Standard Of Care Appears Favorable

FDA Moves Up Oncology Dose Optimization: Dose-Finding Studies Should Be IND-Stage Conversation; Guidance Is On The Way, Pazdur Says

Prevision Policy Clips | Rebate Rule Delay Until Jan. 1, 2026 In Senate-Passed Bipartisan Infrastructure Package

The State Of Accelerated Approval After Aduhelm And ODAC

Senate FDA Appropriations Bill For FY22 Includes Three Directives For Inclusion Of Patient Experience Data In Trials And Product Labeling

Prevision Policy Clips | “Hundreds Of Billions”: Prescription Drug Savings Are Key Offset For FY 2022 Budget Reconciliation Package

Prevision Policy Clips | Biden Administration Rescinds Most Favored Nation Rule, But Will Continue To Evaluate Part B Reforms

“Most Favored Nation” Rule Rescinded, But International Pricing Index Plan Remains As Stealth Option; Biden Team Considers “Future Policy”

FDA Final Guidance On Metastasis-Free Survival As Endpoint In Prostate Cancer Trials Incorporates New PRO Recommendation

Prevision Policy Clips | Metastasis-Free Survival Endpoint Is Acceptable For Castration-Resistant Prostate Cancer, Final FDA Guidance Affirms