J&J Esketamine Breezes Through Committee: “Breakthrough” Antidepressant Will Enter Large Market; Will REMS Work Commercially?

Prevision Policy Clips | House Appropriations Hearing on FDA Postponed

Antibiotic Incentives: President’s Council On Antibiotic Resistance Keeps Ideas Alive; But Will Spark Of Interest Catch Fire?

Prevision Policy Clips | Ways And Means Committee Announces Witness List For Drug Pricing Hearing

J&J Esketamine Headed To Approval, But FDA Wants Restrictive REMS; Committee Will Hear About Unique Studies Supporting Unique Antidepressant

Prevision Policy Clips | Competitive Licensing Mechanism Featured In Medicare Price Negotiation Bill

FDA Psych Division Transition Should Be Smooth As Deputy Farchione Succeeds Mathis; Four Divisions Now Have Acting Heads In Run Up To Re-Org

Prevision Policy Clips | CREATES Act Reintroduced

FDA Combo Product Pathways Guidance Streamlines Safety & Efficacy Information: Combo Filing Does Not Equal To Two Separate Applications

FDA Provides Honest Broker Model For Oversight Of Expanded Use of Real World Evidence In Payment Schemes, Former Commissioners Say

Prevision Policy Clips | Senate HELP Democrats Continue Pressure On Insulin Manufacturers

340B Purchasers Prepare For Transparency Bills In 2019, Hope To Avoid Cuts Amid Drug Pricing Debate

Advisory Committee Tracker: J&J “Breakthrough” Antidepressant Esketamine Kicks Off Post-Shutdown Schedule

Prevision Policy Clips | Seven Pharma CEOs “Invited” To Testify At Senate Finance Committee Hearing

HHS Rebate Rule: Department Asserts Control In Drug Pricing Debate – And Issues Invitations To Industry, Congress To Step Ahead

Prevision Policy Clips | FDA Biosimilars Head Will Be Sarah Yim As Leah Christl Departs for Amgen

House Oversight Committee Appears Headed Toward Support For Familiar, Drug Pricing Proposals; Mostly Small Like REMS; But Part B Reforms May Benefit

Prevision Policy Clips | HHS Secretary Azar Touts $29 Bil. In Discounts Going Directly To Part D Beneficiaries in 2020, Sounds Resolute On Rebate Rule

Drug Rebate Rule Would Protect Medicaid Supplemental Rebates, Value-Based Contracts; New “Safe Harbors” For Point-Of-Sale Discounts, PBM Fixed Fees

Prevision Policy Clips | Mylan Generic To Advair Diskus Approved

Stark/Antikickback Regs Coming This Year, No Update On “Safe Harbor” Drug Rebate Rule

Prevision Policy Clips | FDA Advisory Committee For AllerQuest Skin-Test Kit Is March 27

Reference Pricing And IP “Gaming” Get Screen Time From New Democrats At Oversight Hearing; CEOs To Get Future Invite

NDA/BLA Sponsors Who Submitted Applications During Shutdown Without Fees Have Until Feb. 1 To Pay PDUFA User Fees For Applications To Carry January 28 Receipt Day

Senate Drug Pricing Hearing Focuses More On Themes Of Part D Model Than On Part B “International Price Index”; Rebate “Safe Harbor” Elimination Raised