End The Biosimilar “Fake News”: Execs Call On FDA To Exert Regulatory Muscle Against Misleading Comments From Innovators

Opioid Use Disorder: Limits On Number Of Patients A Physician Can Treat Are Not Primary Barrier To Treatment, Duke Meeting Told; More Work Needed On Outcomes

FDA Rising Stars Panel To Feature OCE's McKee, OND's Smith At Biopharma Congress

Prevision Policy Clips | FDA Confirms Sage Postpartum Depression NDA Advisory Committee Date But Invites Drug Safety

FDA’s Value Proposition: New Drug Reviews Rely On “Accountability, Communication & Consistency;” Updated Good Review Management Guidance Avoids Nuts and Bolts

Pfizer Staph Vaccine Makes Another Appearance At DC Policy Event: CBER Official Says Basic Science Issues To Overcome

FDA ClinicalTrials.Gov Enforcement Policy: Manufacturers Will Receive Two Notices Before Fines Considered

Prevision Policy Clips | FDA’s Updated Good Review Management Practices Guidance

OMB Top Health Budget Official Grogan Nearing Shelf-Life Date; Safe Harbor Rule, Part D Modernization Have High-Level Attention

Prevision Policy Clips | FDA Nuplazid Safety Review of Postmarketing Reports “Does Not Identify Any New Or Unexpected Safety Risks”

FDA Encouraging Early Sponsor/Payor Communication; CDRH Program Has Slow Start, But Expansion Could Spark More Interest

Prevision Policy Clips | CREATES Scored Savings Increases To $3.9 Bil

Chemotherapy Hearing Loss Patient Meeting Reinforces FDA Interest In Otoprotectant Drugs, Strategies; PFDD Forum Has Seven Industry Sponsors

Xtandi and Erleada Pass the ICER Test But Zytiga Falls Short; Panel Questions Discounting, Length of Therapy Inputs in QALY Calculation

Prevision Policy Clips | Product Identifier Requirement Guidance Finalized

FDA Finalizes Opioid REMS; New Legislation Will Shift Focus To Packaging, Quantity Limits

Prevision Policy Clips | Opioid Response Bill: Final Version Could Ready For Votes Next Week

Alnylam’s Onpattro and Akcea’s Inotersen For Amyloidosis: High Cost Means Low Value for ICER Panel As Tensions Rise Over Price

Senate Opioid Omnibus Set For Passage: FDA Authorities Mirror House Bill, But Take Different Approach; Most Payment Provisions Are Not Included

Prevision Policy Clips | FDA Ready To Move On From CV Outcomes Study Requirements In Diabetes?

Cleveland Clinic Considering 503B Outsourcing Facility Status; Drug Shortages Are Driving Major Pharma Customers To Consider Options

FDA Floating Legislation For Diagnostics Oversight: Framework Would Exempt Most Tests From Pre-Market Review, Grandfather Already-Available LDTs

LPAD Pathway Still Uncertain, FDA Acknowledges In Antibiotic Policy Update; “Subscription” Purchase Model Still A Work In Progress

Prevision Policy Clips | Prices in DTC Ads Provision Not in HHS Appropriations Conference Report

House “Gag Clause” Bill Adds Pharmacy Benefit Education; Senate Version Ready To Pass With Biologic Patent Settlement Reporting Included