FDA Overhauling Pain Drug Development Guidance: “Opioid Sparing” Guidance Coming Soon; FDA Notes Opioid Rx Levels Have Fallen To 2004 Levels

Prevision Policy Clips | RMAT Update: One-Third Granted

Prevision Policy Clips | Tetraphase’s Intra-Abdominal Infection Antibiotic Approved

“Non-Traditional” Antibacterials: FDA, Industry See Novel Goals – Not Mechanisms – As Key Regulatory Challenge

Prevision Policy Clips | Monday, August 27, 2018

Prevision Policy Clips | Friday, August 24, 2018

Prevision Policy Clips | Placebo-Controlled Cancer Trials: FDA Wants To Make Sure Unblinding Occurs

CMS MEDCAC On CAR-Ts: Patient-Reported Outcomes Make The Jump To Medicare Coverage Decisions

What If Trump Leaves? HHS May Be Point Of Stability In Chaos

FDA Osteoarthritis Draft Guidance: Starting Over On Structural Claims

Prevision Policy Clips | Senate Opioid Bill to Floor After Labor Day

Prevision Policy Clips | Request for Info on Anti-Kickback Penalties Coming Soon

HHS “100-Day Report” On Drug Pricing Touts Manufacturer Price Restraint, Previews Pending Rebate “Safe Harbor” Rule

Prevision Policy Clips | Senate HELP NIH Hearing Aug. 23

EpiPen Approval May Signal Substitutable Generic Advair May Be Close

Prevision Policy Clips | CRL Four-Day Turnaround?

Prevision Policy Clips | FDA, NIH Propose Removing RAC Review for Gene Therapies

Prevision Policy Clips | FDA's Woodcock Makes The Case For Randomization In RWE Studies

HHS OIG On Open Payments: Some NDCs And Product Names Missing In System, But Less Than 1% Of Overall Records Incomplete

“One Continuous Trial” In Oncology: Expansion Cohorts Guidance Outlines FDA Thinking on When and How To Expand First-In-Human Trials

Prevision Policy Clips | Acting OND Chief Of Staff To Be Khushboo Sharma as Patrick Frey Leaves FDA For Amgen

FDA Continuing Biomarker Efforts with Decision Science Team Pilot; “Cures” Drug Development Tool Process Meeting Planned For December

Prevision Policy Clips | FDA Approves Alnylam’s Onpattro, First FDA Approval of an siRNA

Prevision Policy Clips | Safe Harbor Drug Rebate Rule: Hatch, Walden Ask OMB For Economic Analysis

Medicaid Line Extension Rebate Guidance Details Post-BBA Calculations As Azar Ramps Up The Rhetoric; Rulemaking Coming