FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance; Signal Detection Pilots Will Start In 2019, Take Many Years

Prevision Policy Clips | Nabriva's Contepo PDUFA Date Moves Up Two Months

Prevision Policy Clips | House Oversight Drug Pricing Hearing Will Precede Michael Cohen Testimony

Prevision Policy Clips | Drug Pricing Bills: Same Schtick, Different Day

Takeda’s Uloric: FDA Panel Will Include Previous High-Profile Drug Safety Figures (Nissen and Psaty) As FDA Considers CARES CV Outcomes Trial

Accelerated Approval Trends At FDA: New Uses For Marketed Drugs Drive Recent Use Of Pathway

Prevision Policy Clips | FDA Shutdown Needs To End Soon, Or Biopharma Industry Will Start To Feel The Pain

California Medicaid Could Be New Center For Drug Pricing Reform If Democrats Win White House In 2020

FDA Office Of Drug Evaluation Sciences Is Formally Unveiled; FDA’s Efforts To Stimulate Innovation Are Working – But Stimulating Biotech Investment Is Not

Prevision Policy Clips | California Drug Purchasing Executive Order

Advisory Committee Tracker: Shutdown Hasn’t Affected January Schedule – Yet; Uloric Safety Review Will Kick Off New Year

Prevision Policy Clips | January Advisory Committees Are Still On For Now

FDA “Guidance On Guidances” Sets High Bar For Submissions from Patient Groups; Alternative Options To Interact With Agency Also Emphasized

Prevision Policy Clips | FDA Commissioner Gottlieb: “I Am Not Leaving.”

Prevision Policy Clips | FDA Will Accept New PDUFA-Related Regulatory Submissions for Which No Fee is Required -- INDs, sNDAs, Products with Orphan-Only Indications

340B Payment Cut Overturned By Federal Court: Victory For Hospitals May Have Lessons For Future Rx Cases Against Trump Pricing Policies

FDA Advisory Committee Trends: Panels Voted “Yes” 63% of the Time In 2018; Non-NMEs Fare Worse

Prevision Policy Clips | 340B Payment Cut Overturned In Court

FDA In A Partial Shutdown: No New Applications But Ongoing User Fee Drug Reviews Would Continue If Agency Follows Prior Contingency Plans

Prevision Policy Clips | Pallone’s E&C Top Priorities As New Chair Include Drug Pricing

Cancer Trial Endpoints: FDA Updates 10-Year Old Guidance, But There’s Not Much New

Prevision Policy Clips | Patient Experience Data Development and Submission Draft Guidance

FDA Advisory Committee Gives Leeway For Opioid Labels To Suggest Co-Prescribing of Naloxone – But Would Much Rather See OTC Switch Of Overdose Rescue Agent

Prevision Policy Clips | GSK-Pfizer OTC Business Merger

Prevision Policy Clips | The Return Of Enzi For PDUFA VII?