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

Limited Use Antibiotic Pathway Will Get Limited Use By FDA; Economic Woes Are Key Factor To Address – And More Companies Need To Pay Attention

Prevision Policy Clips | Sage Postpartum Depression Drug PDUFA Date Extension

Medicare Part B IPI Model Hasn’t Prompted Much Feedback On Capitol Hill – Yet

Digital Labeling? FDA Proposal Would Treat Most Rx Industry Apps As “Labeling” Not Requiring Prior Approval

Metastasis-Free Survival Endpoint Guidance For Prostate Cancer: FDA Advises Procedures To Deal With Patient Attrition Due To Rising PSA Concerns

Real-Time Oncology Review: Pilot On Fast Track To Expand – But Sponsors May Need Time To Catch Up

Prevision Policy Clips | FDA Proposes Regulatory Framework For Drug-Related Software

FDA Wary Of “Opioid-Sparing” Claims: Advisory Committee Agrees That Term Is Inappropriate; Post-Market Studies Likely Key To Label Changes