Prevision Policy Clips | FDA’s Unusual Commissioner Transition Continues: Public Letters Of Support For Sharpless

Zolgensma Data Accuracy Concerns Face FDA At Awkward Time: Agency Is Facing Influx Of INDs, Trying To Hire And Train New Review Staff

Prevision Policy Clips | Drug Pricing In A Single Payer System

Prevision Policy Clips | FDA Patient-Focused Guidance Workshop On Incorporating COAs Into Endpoints

Advisory Committee Tracker: Back-To-School Agenda Starts With Peanut Allergy Review; Amarin REDUCE-IT Review Is Unexpected Addition

Placebo-Controlled Trials In Cancer: FDA Says Unblinding Should Occur At Progression Or Recurrence Only With Investigator, Patient

Prevision Policy Clips | FDA Unified Review Pushback: Former FDA Panelists, Reviewers Object

Prevision Policy Clips | Gene therapies account for more than 800 active INDs

FDA Office of Antimicrobial Products To Be Led By Deputy Farley Following Departure Of Longtime Director Ed Cox To Regeneron

Prevision Policy Clips | FDA Leadership From Drug, Biologic, and Oncology Centers To Provide Updates On OND Reorg, Address Top Priorities for 2020

Prevision Policy Clips | FDA Male Breast Cancer Guidance Reflects Recent Ibrance Approval

Bipartisan Policy Center Real-World Evidence Report Highlights Potential CMS Role In Supporting FDA Efforts

Prevision Policy Clips | Biopharma Congress Draft Agenda Now Available

Prevision Policy Clips | HHS to Appeal DTC Court Ruling

Biosimilars Reform Act? Senate Drug Pricing Bills Attempt To Improve The Pathway

FDA Pediatric Opioid Review Will Cover Post-Market Safety Of OxyContin, General Labeling Framework

Prevision Policy Clips | TherapeuticsMD Settles SEC Case Over FDA Disclosures

Prevision Policy Clips | Another Sarepta Controversy? FDA Rejects Golodirsen For DMD

Prevision Policy Clips | A Busy Week For August Approvals: FDA Clears Five NMEs Aug 12-16

“March-In” Is Out-Of-Step As Price Control Tool: Even Advocates For Pricing Actions See NIH Intervention As Impractical During NASEM Panel

Prevision Policy Clips | Who Needs Juul? GSK Consumer Nicotine Oral Spray OTC Application Will Be Reviewed

GAO PBM Report: Rebates Are 20% In Part D, PBMs Keep Very Little; Plan-Level Analysis Shows No Correlation Between Rebate Levels, Net Spending

Prevision Policy Clips | TB Alliance’s Pretomanid Approved Under LPAD Pathway

Prevision Policy Clips | GAO Report On PBMs Finds Rebates Represent 20% Of Part D Spending

The “Age Of Individualization”: Key Takeaways From FDA Meeting On Precision Dosing