WorldMeds’ Lofexidine Opioid Withdrawal Product Comes To FDA Committee At Good Time, But Claim For Completion of Opioid Discontinuation Treatment May Be a Hard Sell

Complex Innovative Trial Designs: FDA Seeks Two Pilot Projects Per Quarter To Gain Experience, Start Industry-Wide Conversations

Prevision Policy Clips | Oncology Center of Excellence To Get $15 mil. In Funding

FDA Vexed By Outdated Drug Labeling; Agency Needs Legislative Authority To Update Older Generics

FDA Endorses Several House Opioid Bills – But Not AA/Breakthrough Pathway For Pain; Agency Promises Data Soon On Abuse-Deterrent Impact, Current Excess Prescribing

Prevision Policy Clips: House Passes "Right-to-Try" Bill

Patient-Developed Guidances May Be Too Big A Step For Patient Groups, Not As Useful To FDA Reviewers

Prevision Policy Clips | Achaogen’s cUTI and Bloodstream Infections Drug to Advisory Committee May 2

DMD Master Protocol Under Development; FDA Eager To Push Master Protocols More Broadly – But Is Rare Disease The Best Fit?

FDA Showcases Flexibility For Rare Disease: Agency Ready To “Move Beyond” P-Values—With Appropriate Planning And Discussion

Prevision Policy Clips | Janssen’s Erleada Extensive Clinical Study Report Posted Online By FDA

Clinical Data Summary Pilot: J&J Goes First With CSR For Erleada; Redactions Include CROs, Patient-Level Data

Trump/Azar Promise Drug Pricing Announcement Next Month, Likely Related to Part D Rebates At Point of Sale

Real World Evidence And The "Mulligan Problem": NASEM Workshop Notes Concern About Rapid Repeat Attempts To Get Positive Results

OCE Structure Changes Coming: Is Pazdur Consolidating Power?

Prevision Policy Clips | Is 60 the New 70? 60-20-20 Budget Deal Fix Gains Momentum

Pediatric Oncology Molecular Targets: FDA Meetings In April and June Continue Renewed Focus On Childhood Diseases

Prevision Policy Clips | House Hearing to Review 25 Opioid Bills Next Week, Including Several Related to FDA

Medicare B-To-D Shift For Drugs Remains Live Topic In HHS Budget Testimony; Secretary Azar Also Endorses Public Health Emergency Fund

Senate 340B Hearing Provides “Sympathetic” Forum For Hospitals – But Sen. Alexander Still Wants To Know Where The Discount Goes

Prevision Policy Clips | Lilly/Incyte Baricitinib Heads to Advisory Committee April 23

Prevision Policy Clips: House “Right-to-Try” Bill Fails – For Now

FDA Drug Safety Meta-Analysis Guidance Coming Soon: Will Emphasize "Totality Of The Evidence" And Multi-Disciplinary Input

Will FDA Sack the SAC? Reassessment of "Safety Assessment Committee" For IND Reporting Is Key Theme Of Duke Event

Prevision Policy Clips | President’s Cancer Panel Report Endorses Value-Based Pricing Models, Biosimilars