Cures II: What To Watch In The Years Ahead

HHS Management Of Medicare Does Not Give It Authority To Control Drug Prices: DTC Ad Ruling May Carry Broader Implications

Prevision Policy Clips | E&C Committee To Mark Up Drug Price Transparency Bill Package July 17

Prevision Policy Clips | Register Now For The Biopharma Congress October 7 In Washington, DC

Prevision Policy Clips | Grassley Weighs In On Rebate Rule Withdrawal, Not A Fan

Drug Pricing Transparency “METRIC” Act Clears E&C Health Subcommittee With Full Committee Markup Slated For The Week Of July 15

Rebates Redux: Rebate Rule Withdrawal Opens Drug Price Reform To Less Appealing Options For Pharma, Including Non-US Reference Prices, Arbitration

Prevision Policy Clips | International Pricing Index, Importation Emerge As Rebate Rule Is Officially Withdrawn

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FDA Chronic Heart Failure Draft Guidance, Public Workshop Intended To “Spark” New Drug Development Efforts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