MedPAC Wants To Tamp Down Separately Payable Drugs In Hospital Outpatient Setting: NTAP-Style Clinical Improvement Standard May Be One Outcome

Prevision Policy Clips | White House Forwards Drug Pricing "Principles" To Congress, If Anyone Is Paying Attention

CDER Meetings Cancelled Through April, Woodcock Says; Foreign Inspections Postponed

Biosimilar Competition: FDA/FTC Workshop Highlights Glass Half-Full Picture Of Market; “Level Playing Field” Arguments Reflect Brand v. Brand Dynamic

Prevision Policy Clips | FDA Postpones Nonprescription Drugs Advisory Committee, Gene Therapy Conference, Vitiligo Patient Meeting

Diabetes Safety Guidance Goes Beyond CV Risk To Consider Broader Outcomes; FDA Drops “Goalpost” Approach

Prevision Policy Clips | FDA Announces “Updated Approach” To Diabetes Safety; No More "Goalpost" Approach

Rx Addiction Training Standards: House Weighs Bills To Ease Rules For Treatment, Mandate Training For Pain/Stimulant Scripts; Neither Likely To Move Quickly

Prevision Policy Clips | FDA Panel Meetings In April, May Are Still On Despite COVID-19 Concerns

Ultra-Rare Gene Therapy: Industry Support For Non-Commercial Model May Help Build “Goodwill,” FDA’s Marks Suggests

MedPAC Part D Overhaul Plan Set For Vote In April: Rx Discount Likely To Be Set Above 20%; Another Tweak May Allow Rebate-Free Plans Sooner

FDA Draft Guidance Encourages Flexible Designs To Enroll “Older Adults” In Cancer Trials, With Special Focus On The Over-75 Population

Prevision Policy Clips | FDA’s First Budget Hearing Set For March 11

COVID-19 Funding Bill Includes $61 Million For FDA, $3.1 Billion For Countermeasures: “Fair” Pricing Language Cites Government Contracting Rules

“Deeming Day” Final Preparations: FDA Says NDC Codes Should Not Change, Maintains Five-Year Timeline For Sponsors To Update Labels

Pharmaceutical Nationalism: Senate Coronavirus Hearing Spotlights Foreign API Dependence; Commissioner Hahn’s Baptism By Fire

Prevision Policy Clips | “Deeming Day” Final Preparations: FDA Says NDC Codes Should Not Change, Maintains Five-Year Timeline For Sponsors To Update Labels

Prevision Policy Clips | HHS, CMS, DEA To Testify On Substance Use Bills

Prevision Policy Clips | Supreme Court To Hear Texas ACA Challenge In The Fall, Drug Pricing In Limbo Until 2021?

Prevision Policy Clips | First Drug Shortage Related to Coronavirus; FDA Not Disclosing Name

Advisory Committee Tracker: GSK Trelegy Mortality Claim Highlights Trio Of Newly Announced Reviews

Lilly Cyramza First-Line Lung Cancer Claim Narrowly Clears Committee; The Long Shadow Of Avastin Lingers – But Lilly’s Reputation May Help Garner Approval

Rare Disease Center Of Excellence Pushed By EveryLife: FDA Has Authority But Congress Being Asked To Weigh In; Possible “Cures 2.0” Theme

Prevision Policy Clips | Drug Importation Proposed Rule: HHS Secretary Azar Welcomes Legislative Fix For Insulin

Steba’s Tookad For Early-Stage Prostate Cancer Shot Down By FDA Advisory Committee; Confirmatory Trial Results Expected In 2030