Advisory Committee Tracker: Anti-Infectives Featured In Unusual Mix Of April Meeting Topics

House Insulin Hearing Tees Up Questions For Manufacturers Next Week; Bipartisan Approach By DeGette Offers Relatively Favorable Context For Testimony

Prevision Policy Clips | Cigna/Express Scripts Announces $25 Cap on Insulin Ahead of Pharma/PBM Insulin Hearing April 10

Rebate Rule Delay Seems Certain Given Absence From Final Medicare Part D Call Letter

Interchangeable Insulin: FDA Public Meeting Continues Rhetorical Push – But Underscores Slow Moving Path With Biosimilar Transition

Prevision Policy Clips | CREATES, "Pay For Delay" Among Drug Pricing Bills Slated For Markup By Full House E&C Committee on April 3

Prevision Policy Clips | GOP Senator Proposes “International Retail List Price Index” Bill

Pfizer Looking At Dashboard Updates On Clinical Trial Progress For Patients As One Way To Start Data Sharing

Prevision Policy Clips | CMS Implements BBA Change On Medicaid Rebates for Line Extensions, Score Lowered

FDA Is Moving Ahead On Comparative Safety, Efficacy Requirement For New Opioids; Gottlieb Says Opioids Demand Higher Standard To Earn Approval

CREATES, “Pay-For-Delay” Bills Pass E&C Health Subcommittee As Generic Drug Pricing Responses; Work Will Continue Before Full Committee

Prevision Policy Clips | TIRF REMS Requirements Strengthened, More Actions May Be Coming

OCE Highlights Importance Of Supportive Data, Early Inclusion Of Patients In Trials At CNS Metastases Product Development Workshop

Naloxone Price Negotiation Unnecessary Given Narcan Popularity And Affordability, HHS’ Hargan Testifies To House Budget Committee

Prevision Policy Clips | Gilead’s Asegua Authorized Generic Subsidiary Chosen By Louisiana As Hep C Subscription Partner

FDA Highlights Best Practices For Natural History Studies And External Controls In Rare Disease Drug Development Guidance

Prevision Policy Clips | CREATES Act Among Six Drug Pricing Bills Set For House E&C Markup On March 27

Prevision Policy Clips | Senate Appropriations FDA Budget Hearing Thursday

Prevision Policy Clips | Chiesi/Pharmaxis Bronchitol For CF Returns To Advisory Committee May 8

FDA Reorg: Commissioner’s Office Plan Will Be Implemented As Gottlieb Leaves; Phase One In CDER Revamp Also Ready To Go – But OND Overhaul Still Pending

Prevision Policy Clips | Vivitrol For All? OUD Medications Should Be Available For All People

Medicaid Rebates On Specialty Drugs Hit 50% Of AMP; Part D Achieved Just 14% Rebates At Retail -- CBO Analysis Shows

Prevision Policy Clips | DTC List Price Final Rule Goes To OMB

Pediatric HIV Final Guidance Recommends Adolescent Enrollment In Phase III Trials, Neonate Inclusion Based On Older Pediatric Patient Experience

Prevision Policy Clips | CBO Specialty Drug Prices & Spending Report