REMS Revisions Final Guidance Redefines Measuring Stick For Assessing Changes To Programs Requiring Advance Notice To FDA

ICER 2020 Drug Topics List Targets Wave Of Innovative Therapies; Most Not Yet FDA-Approved

Prevision Policy Clips | Expanded Drug Price Increase Justification Bill To E&C Markup July 11

Prevision Policy Clips | DC Federal District Court Whacks "WAC Disclosure Rule:" DTC Price Disclosure Vacated

Prevision Policy Clips | International Pricing Index Proposal For Part B Previewed By President Trump

Prevision Policy Clips | Karyopharm’s Selinexor Overcomes Negative ODAC, Concerns Over Single-Agent Activity With FDA Approval

DMF Proposed Rule May Add Technical Barrier To Biosimilar/Interchangeable Insulins

Prevision Policy Clips | Part D Formularies Continue To Include Essentially All Commonly Used Drugs By Dual Eligibles, OIG Finds

Prevision Policy Clips | Azar/Grogan Pen Drug Pricing Op-Ed Referencing Rebate Rule In NY Post

Prevision Policy Clips | FDA Foreign Inspections Are Focus Of Energy & Commerce Letters

FDA Recommends Ways to Minimize Patient Visits to Trial Sites in Epidermolysis Bullosa Guidance; Focus on Comfort and Modern Data Collection May Have Broader Use

FDA Chronic Heart Failure Draft Guidance, Public Workshop Intended To “Spark” New Drug Development Efforts

Prevision Policy Clips | Epidermolysis Bullosa Guidance Finalized; Krystal Biotech Gets RMAT For EB Gene Therapy

“Product Hopping” Is Potent Theme In Judiciary Committee Pricing Bill; “Patent Thicket” Proving Thorny Subject For Legislation, But Second Effort Moves Forward

FDA Likely To Drop CSR Posting In Favor of “Uni-Review”: Feedback Notice Asks For Input On How Best To Reflect “Issues That Concerned” Review Teams

CREATES Act Moves With Senate HELP Package: Full Senate Vote Expected In July; Price Increase Justification Amendment Added

Prevision Policy Clips | Heart Failure Drug Guidance Says Symptom Or Physical Function Improvement A Suitable Endpoint

Advisory Committee Tracker: Gilead Descovy Review Highlights FDA’s Summer Agenda; Discussion May Get Heated – Real Focus Is Future Of Truvada Generics

Prevision Policy Clips | FDA Seeking Feedback On Failed Clinical Data Summary Pilot

Register Now: Biopharma Congress V On October 7, Confirmed Speakers Include Woodcock, Pazdur, Marks

MedPAC Recommends ASP Model For CAR-Ts In Comments To CMS, Pitches Baseball-Style Arbitration

FDA “Integrated Review Template” Available For Feedback; Upcoming Federal Register Notice Will Solicit Comment On New Review Documentation Model

Prevision Policy Clips | White House Executive Order On Price Transparency Focuses On Hospital Charges, Not Drug Prices

Peanut Allergy Products Have “Promising But Inconclusive” Evidence, ICER Panel Says; Lack Of Quality Of Life Data Cited As Flaw In Development Plans

Prevision Policy Clips | FDA Commissioner Candidates: What If It Is Not Sharpless?