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

Biopharma Congress IV Top Takeaways

Michigan Goes Second On Medicaid Value-Based Contracts, More Likely To Follow With Quicker Pace

Prevision Policy Clips | HELP Committee FDA Oversight Hearing December 5

FDA Office Of New Drugs Director Search Nearing Completion; Deputy Director Peter Stein Remains Likely Choice

Prevision Policy Clips | Mallinckrodt Gets Close "Yes" Vote for Abuse-Deterrent IR Oxycodone

Prevision Policy Clips | Opioid Dosing Advisory Committee Meeting Announced

FDA’s Oncology Leaders Say “Breakthrough” Is Not Rating System For Wall Street; Readying Generic Label Updates For Older Agents

Prevision Policy Clips | Informed Consent Exception For Minimal Risk Experiments Proposed Rule

Extended-Release Opioid Use Disorder Treatments Have Low Value – But Patients Should Get Access, ICER Panel Says

Prevision Policy Clips | Cardiac Rehab, Oncology Demo Revivals Likely Coming, HHS Secretary Alex Azar Says

Prevision Policy Clips | Gottlieb Talks Opioids, New Framework at NCCN/ASCO

FDA Meta-Analysis Guidance: “Quality Over Quantity” Is Key Theme

Midterm Elections Deliver Expected Outcome As House Flips, GOP Keeps Reins In Senate; Health Agency Changes Will Be Next Key Variable To Watch

Prevision Policy Clips | FDA Making MyStudies App Code Available More Broadly To Facilitate Real World Data Collection

Advisory Committee Tracker: Opioid Abuse Back To Center Stage With Mallinckrodt ADF Review, Two Broader Meetings Set For Fall

Prevision Policy Clips | FDA’s Overdue Safety Meta-Analysis Draft Guidance

Sage’s Brexanolone For Postpartum Depression Headed For Approval With REMS After Positive Panel; Dosing Strategy Punted Back To FDA