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Prevision Policy Clips | FDA’s Overdue Safety Meta-Analysis Draft Guidance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

CMS Promises Further Work On Incentives To Use Non-Opioid Pain Therapies; Finalizes Exparel Carve-Out For Ambulatory Centers

Cystic Fibrosis Treatment Burden Grabs FDA Attention At Oct. 29 Patient Meeting; Reducing Length Of Regimens Is Next Challenge

Prevision Policy Clips | AcelRx’ Dsuvia Approved As Trevena Receives CRL For Oliceridine

FDA Makes A Statement With AcelRx’ Dsuvia Approval; Gottlieb Says Novel Comparative Benefit-Risk Framework For Opioids In Development

Prevision Policy Clips | HHS Drug Pricing Senior Advisor Dan Best Dies

Alkermes’ ALKS-5461 Antidepressant Voted Down By FDA Advisory Committee Based On Lack Of Efficacy; Another Trial Needed

FDA Hemophilia Product Development Meeting Signals Measured Approach To Defining Accelerated Approval Pathway

Prevision Policy Clips | Questions About International Price Indexing? HHS Has Answers – Sort Of

Biopharma Congress Final Agenda: Only Two Weeks Away

Sage’s Brexanolone Poised For Approval As First Post-Partum Depression Therapy, But Only For Clinic/Inpatient Use

The Influencers: Prevision Policy’s List Of Advisory Committee Members With The Most Impact On Drug Reviews

Prevision Policy Clips | 340B Pricing Rule Effective Date Change Clears OMB:

Subscription Pricing Plays Well With Media: “Netflix Model” Makes Topic Sound Fresh, Supportive Of More Content (i.e., More Therapies)