PRECISION Trial Appears To Answer Celebrex CV Profile Questions Relative To Other NSAIDs As FDA Attempts To Write Final Chapter Of COX-2 Safety Era

Prevision Policy Clips | “That’s On Us”: FDA Commissioner Gottlieb Acknowledges Cautious Approach

Lilly Baricitinib 4 mg Is Long-Shot At FDA Committee Due To Thrombotic Concerns; 2 mg Dose Could Pass; FDA Leaned Toward Approving In 2017

Democratic Senators Want Opioid Manufacturers To Testify, But Bipartisan Legislation To Combat Epidemic Would Come First

GW’s Cannabidiol For Rare Forms Of Epilepsy Headed For Near-Term FDA Approval After Smooth Panel Review; Agency Likely To Beat June 27 Action Date

FDA, Industry Ready To Rethink Clinical Trial Inclusion Criteria– But Broader Use Of Expanded Access Is Key To Blunting “Right-To-Try”

Prevision Policy Clips | NIH Offers License To Universal Flu Vaccine Candidate

Opioid Use Disorder Trial Endpoints Should Include Drug “Craving,” Patients Tell FDA; Response Supports Planned Draft Guidance

FDA Pulmonary Division Shakeup: Safety Deputy Seymour Named Interim Director Following Chowdhury Exit; Deputy McClain Retiring

DEA Ready To Cut Production Quotas; Manufacturers May Be Required To Include Customer Data In Quota Application

Prevision Policy Clips | Metered Dose/Dry Powder Inhaler Draft Guidance

FDA’s Push For Consistency: Gottlieb Outlines “Knowledge Management,” Guidance Priorities In Budget Hearing, Promises To “Take Another Look At” Nuplazid Safety

GW Pharma Cannabidiol Appears Headed To Approval; FDA Briefing Documents For Committee Positive For Both Lennox-Gastaut and Dravet Seizure Indications

Prevision Policy Clips | FDA Finds GW Pharma’s Cannabidiol Safe and Effective

Metered Dose/Powder Inhaler, Transdermal Generic Guidances Coming Soon, FDA Tells Two-Day Forum; Agency Continues To Urge Higher Quality ANDAs

Prevision Policy Clips | White House Drug Pricing Event Tentatively Set For April 26

Prevision Policy Clips | FDA Finalizes SPA Guidance

FDA Streamlining Review Of Oncology Diagnostics For Clinical Trials; Process Now Overseen By Oncology Center For Excellence

Abuse-Deterrent Opioid Coverage Needs Legislative Attention, CMS Tells House Committee; Agency Does Not Tip Hand On Other Coverage Ideas For Opioid Response

Prevision Policy Clips | FDA Finalizes Two NextGen Sequencing Guidances And Releases New Draft Guidance

FDA Opioid-Related Reforms Moving Towards Senate Mark-Up; Other Provisions Focus On Areas Where Pharma Can Help – New Treatments For Pain And Addiction

Prevision Policy Clips | FDA Commissioners Slated for Reagan-Udall Annual Meeting May 4

Epidermolysis Bullosa PFDD Meeting: Patients Emphasize Importance of Endpoints Beyond Wound Healing; Five Companies Support PFDD Meeting

Pain Relief Emerges As Most Desired Treatment for Pachyonychia Congenita at PFDD Meeting

Prevision Policy Clips | AbbVie/Neurocrine’s Elagolix NDA Review Extended 3 Months