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?

Prevision Policy Clips | IPI Goes To OMB

Comparative Efficacy And Safety Considerations For Approval Of New Opioids Outlined In FDA Guidance

Prevision Policy Clips | Opioid Comparative Safety/Efficacy Standard To Existing Therapies Suggested In Draft Guidance

Orphan Drug Exclusivity, Generic Labeling Modernization Provisions Are Newbies In Senate HELP Cost Bill; Markup Set For June 26

Insulin Will Be Marker Of Success Of Medicare Part D Rebate Rule; Congress Makes Clear It Will Be Watching For Further Price Decreases

Prevision Policy Clips | Generic 180-Day Exclusivity Decision Status Added To "Orange Book"

PBM/Insurer Mergers Will Facilitate Medical/Pharmacy Benefit Alignment, Economists Tell Senate Hearing; May Increase Pressure On Specialty Drugs

Drug Price Justification Provision Needed In Senate HELP Bill, Democrats Say, But Prospects For FAIR Act Appear Slight; Markup Slated For Next Week

Prevision Policy Clips | NASEM July 24-25 Workshop on NIH Role In Drug Development Is Sponsored By Arnold Foundation

Prevision Policy Clips | DTC Drug Price Disclosure Rule Challenged In Court As First Amendment Violation

Prevision Policy Clips | DEA Places Sage's Zulresso (brexanolone) in Schedule IV

FDA Unlikely to Remove High-Dose Opioids from the Market, May Consider Tougher REMS

Biostatistics Role In OND Overhaul Could Curb “Rogue” Reviewer Problems, Califf Says; Does FDA Have To Worry About Rogue Ex-Commissioner?

HHS IG Review Of Compounding Sources For Hospitals Finds FDA’s Efforts Effective: 89% Use Registered “Outsourcing Facilities”