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)

Lilly Opposes Broad Scope Of CMS Coverage Decision On Alzheimer MAbs; Biogen Urges Flexibility In Type Of Provider, Treatment Setting Allowed For Aduhelm

Prevision Policy Clips | CDER Director Cavazzoni In The Hot Seat? July 29 House Hearing

Advisory Committee Tracker: Gene Therapy Safety Update Is Highlight On Otherwise Sparse Agenda

Prevision Policy Clips | ANDA Filing Fee To Increase Almost 15%, FDA Says

Prevision Policy Clips | Bristol Withdraws Opdivo Hepatocellular Carcinoma Monotherapy Indication, One Of “Dangling” Accelerated Approvals

Prevision Policy Clips | FDA Adcomm to Discus Toxicity Risks of AAV Vector-Based Gene Therapies

CMS Views Aduhelm NCD As Class Coverage Decision With April 2022 Final Deadline

Prevision Policy Clips | Biogen Welcomes “Formal Review” Of FDA-Sponsor Interactions On Aduhelm

Avoiding The Next Addiction Crisis? Benzodiazepine Research Agenda Includes Deprescribing, Better Tapering Instructions, And Treatment Alternatives

Prevision Policy Clips | North Carolina GOP Sen. Burr Supports Woodcock for FDA Commissioner – and Aduhelm AA Decision

“Operation Warp Speed” Changing Gears To Long-Term HHS Countermeasure Preparedness; Supply Chain, Vaccine Boosters Are Key Issues At Senate COVID Update Hearing

Prevision Policy Clips | CBER Still Working Out "Relatively Complicated-Looking" Transition Period For COVID-19 Vaccines Out Of EUA Status

Thicket Pruning Ideas From Fresenius Would Cap Patents Asserted Against A Biosimilar; Sen. Klobuchar Shows Renewed Interest

Prevision Policy Clips | AbbVie, Lilly/Incyte JAK Inhibitor Reviews Will Miss PDUFA Dates As FDA Safety Review Continues