Prevision Policy Clips | George H. W. Bush’s Legacy For Pharma

GAO Orphan Drug Report Could Fuel Criticism Of Market Incentives; Imbruvica, Avastin Mentioned As Drugs With Multiple Orphan Indications

FDA NASH Guidance Offers “Either/Or” Approach To Accelerated Approval: Fibrosis, Steatohepatitis Both Acceptable Surrogate Endpoints

FDA Previews Drug Development Qualification Process Guidance Ahead Of Dec. 11 Meeting; Suggests 8-10 Month Timeline For Review Of Final Packages

Prevision Policy Clips | DDT Meeting Materials Posted

ICER Views Sanofi/Regeneron’s Dupixent Value As Less In Asthma Than Dermatitis, Discusses Indication-Based Prices; Differentiation Among Asthma Biologics Works Against Step Therapy

Senate Finance Committee Will Set Boundaries For Pricing Legislation In 2019: CREATES, Medicaid Rebate Reclassification Likely, Limited Canadian Imports Is Wildcard Threat

Prevision Policy Clips | NASH With Liver Fibrosis Drug Development Draft Guidance

Biopharma Congress IV Note Collection

Advisory Committee Tracker: CV Safety Theme Will Continue In First 2019 Meetings, Including Uloric Outcomes Trial, Amgen Osteoporosis Antibody

Prevision Policy Clips | CMS NTAP Town Hall December 4

Office Of New Drugs Reorg Seeks Processes To Ensure Greater Review Consistency; Slow Rollout Provides Time To Find New Leadership

FDA Glossary Of “Patient-Friendly” Oncology Clinical Trial Terminology Gets Thumbs Up From Patient Advocates At OCE Meeting

Prevision Policy Clips | 340B Pricing Rule Takes Effect Jan. 1

FDA Urging Gene Therapy Sponsors To Think Big: “Quantum Leap” In Manufacturing Capacity Will Herald Next Step For Evolving Therapies

Lame Duck Standoff Threatens OTC Monograph Bill, Biodefense Reauthorization; FDA’s Office Of New Drugs Overhaul Could Be Delayed As A Result

Prevision Policy Clips | 340B Pricing Reg Effective Date Change Final Rule at OMB

Prevision Policy Clips | CMS Gives Part D Plans New Tools For Excluding Specific Products In Protected Classes

CMS Gives Part D Plans New Tools For Excluding Specific Products In Protected Classes: Above-Inflation Price Increases Can Justify Dropping Products

Prevision Policy Clips | E-Submission For Adverse Event Reporting Meeting Jan 25

Major Depressive Disorder Patients Emphasize Long-Term Nature Of Disease, Desire For Fewer Side Effects; PFDD Occurs During Active Development Period

Prevision Policy Clips | IPI Beyond Medicare?

Rethinking Expanded Access: FDA Encouraging Use Of EA Data To Support Approval Decisions – Stresses Opportunity Rather Than Risk To Sponsors

FDA’s New Guidance Approach Working Well For Review Teams; Clearance Timeline Is Better, and “Just Say It” Model Appears To Be Paying Off

It Never Hurts To Ask: Breakthrough Request Conversations With FDA May Be As Important As Designation Itself