PAHPA House Draft Headed for Introduction Later This Month; PRVs, Antibiotics Incentives Highlighted During Exchange With FDA’s Abram

Prevision Policy Clips | Ex-FDAer Lisa Lavange Takes on Trump

OND Reorg First Impressions: Oncology Still First Among Equals, Big Changes For Neurology, Biosimilars

Prevision Policy Clips | HHS Proposing Working Group On “Investment and Innovation”

REMS “Abuse” Bill Moving As Part Of Opioid Response: Senate Judiciary Committee Sets June 7 Mark-Up

FDA Commissioner’s Office Reorganization Will Precede OND Revamp; Goal Will Be Stability In Political Transition

Prevision Policy Clips | Neulasta Biosimilar Approved Without Advisory Committee

OIG Part D Brand Expenditure Review Indicates That Giving Plans More Tools Against Non-Rebated Drugs Could Be Quite Effective

Prevision Policy Clips | Office of New Drugs Reform Proposal Unveiled: 30 Review Divisions

FDA Looking To Standardize Cell-Based Manufacturing Processes, Gottlieb Says; “Clear Requirements” Could Expand Opportunities

FDA Oncology Pilot Programs Will Speed Review Of Efficacy Supplements; Expansion Outside Cancer A Longer-Term Possibility

Adolescents In Cancer Trials: FDA Guidance Urges Simultaneous Enrollment With Adults, Makes Broad Dosing Recommendations

Advisory Committee Tracker: FDA Confirms Remoxy Return Visit To Committee; Opioids Still Dominating Panel Topics

Prevision Policy Clips | Right to Try Sponsor Says Law Meant to “Diminish” FDA’s Power

FDA Shared REMS Guidances Take Carrot-And-Stick Approach; “Benefits” Of Shared Model Emphasized – But Expect Liberal Use Of Waivers

Cassidy Healthcare Position Paper Suggests Time Is Approaching For Another “Grand Compromise” On Drug Exclusivity

Prevision Policy Clips | A New Voluntary Pricing Pledge Coming Soon?

FDA Recommends Continuous Blood Pressure Monitoring For All Chronic Use Drugs In Development In Draft Guidance

Prevision Policy Clips | FDA Guidance On Assessing Blood Pressure Effect Of Drugs

Prevision Policy Clips | Loxo Larotrectinib PDUFA Date Set for November 26

Insurers Explore New Payment Models For High-Priced Curative Therapies; New Risk-Bearing Entities, Premium-Based Fund Discussed

Prevision Policy Clips | Lifting Protected Classes In Part D, Moving B Likely Get First Political Test

Senate HELP Moves PAHPA With 22-1 Vote: Lingering Debate Over New Flu Vaccine Technologies Versus More Stockpile Purchases

Prevision Policy Clips | Toxicology Roadmap Highlighted by FDA Commissioner

Hemophilia Gene Therapy Guidance May Permit Accelerated Approval Based On Clotting Factor Levels; FDA Eager For Input On Other Specific Disease Areas For Future Guidance