Prevision Policy Clips | NIH Director Francis Collins to Testify at Appropriations Committee Hearing April 11

US WorldMeds Lucemyra (Lofexidine) Gets FDA Advisory Committee Okay for Mitigation of Opioid Withdrawal Symptoms; Lower Dose Urged By Committee

Prevision Policy Clips | Insys Buprenorphine Sublingual Spray Advisory Committee Meeting

Prevision Policy Clips | Senate Opioid Discussion Drafts Address Areas of Interest for FDA

Combination Products: FDA Delays FAERS Reporting Compliance By One Year; Draft Guidance Includes Specific Examples

Prevision Policy Clips | ICER Final Report on CAR-T Therapies Calls for Changes to Ensure Affordability and Access

Compounding Guidance Puts Drug Approval Process and Approved Products First, Sets Narrow Parameters Around Bulk Substances For Outsourcing Facility Compounding

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FDA Vexed By Outdated Drug Labeling; Agency Needs Legislative Authority To Update Older Generics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