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“Most Favored Nation” Rule Rescinded, But International Pricing Index Plan Remains As Stealth Option; Biden Team Considers “Future Policy”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

Prevision Policy Clips | Most Favored Nation Proposed Rule Clears OMB

OIG To Take On Aduhelm-Instigated Review Of Accelerated Approval Processes; Target Completion Date In 2023; OIG Says It Will Not Second Guess Scientific Decisions

CMS New Technology Add-On Payments For Fiscal 2022 Were Tougher To Get; FDA Delays Block Four

Prevision Policy Clips | Complex Trial Designs For Pediatric Therapeutics: FDA Public Workshop September 1-2

Prevision Policy Clips | CMS Approves 10 New Drug NTAPs for FY 2022

Part D Inflationary Rebates Supported By Arnold Ventures In Combination With Benefit Redesign

FDA “Conditional Approval” Pathway Gets Bipartisan Interest In House Hearing

Prevision Policy Clips | RWD Standards Guidance Is One Of Four New Titles Added To CDER CY 2021 Agenda: July Updates

Prevision Policy Clips | NEJM Aduhelm Decision Defense By FDA Top Drug Review Managers Includes CDER Deputy Director Clinical Science Bob Temple

Accelerated Approval Development Plan Endorsed By FDA’s Pazdur In Conversation With “Cures 2.0” Co-Sponsors; Don’t Let Critics “Define” AA, He Warns

Prevision Policy Clips | Biosimilar At Last: FDA Grants Landmark Designation To Viatris’ Insulin Glargine (Semglee)