FDA Edging More Compounders To GMP Standards By Moving Up To Outsourcing Facilities; Revised Guidance Sets Risk-Based Thresholds

Prevision Policy Clips | Part D Rebate Savings Would Be $154 Billion Over 10 Years

Fetal Tissue Research Alternatives Explored During House Hearing; Truvada, CAR-T Cited As Examples Of Why Substitutes Will Not Work In All Diseases

Generic Labeling Rule Formally Withdrawn, As FDA Still Seeks Legislative Support For Alternative Approach

Public Health Vs. Public Purse: FDA Asks Advisory Committee to Consider Naloxone Co-Prescribing In Economic Terms

Prevision Policy Clips | FDA Formally Withdraws Generic Labeling Rule

Drug Development Tool “Qualification Plan” Is Key To New Process, FDA Says; Learning Curve For Reviewers – And Hiring Obstacles Remain

Mission Accomplished on Drug Pricing? HHS’ Azar Says Most Blueprint Items Have Already Been Implemented; Senate Health Chair Wants Broader Focus On Healthcare Costs

Biomarker Benefit/Risk Ratio: FDA Guidance Outlines Evidentiary Standards For Qualification Of Novel Markers

Prevision Policy Clips: Data Integrity And Compliance With Drug GMPs Guidance Finalized

FDA Finalizes NDA-to-BLA Deeming Process Guidance For 2020 As Part Of Broader Biosimilars Strategy; Insulins Likely First Interchangeables

Prevision Policy Clips | Insulins to Be First Interchangeable Biosimilars in 2020?

Hemophilia And Accelerated Approval: Factor Activity Useful Surrogate Despite Assay Variability, Expert Panel Tells FDA

LDT Reform Teed Up For 2019? “VALID Act” Would Apply FDA’s Model, Including Pre-Approval For Companion Diagnostics

Prevision Policy Clips | CBO Scores On OTC Monograph Reform and PAHPA Reauthorization

FDA Makes It Official: OND Director Is Peter Stein; Temple Moving Out Of ODE 1 To Senior Advisor Role To Stein, Will Remain CDER Deputy

Class Labeling For Companion Diagnostics In Cancer Urged By FDA In Draft Guidance; Lung Cancer Used As Case Study

Prevision Policy Clips | LDTs Discussion Draft Includes Pre-Certification Program

New Technology Add-On Payments: 11 Drug Candidates for FY2020 Presented At CMS Town Hall; Industry Groups Seek Greater Interplay with Breakthrough

Prescription Drug Spending Growth Drops Below 1% In Latest CMS Data; Bad Business May Make A Good Headline Amid Push For Rx Pricing Reform

FDA Real World Evidence Framework Promises Ample Guidance – But Stops Short Of Promising RWE-Based Approvals; Initial Focus Will Be Supplements

Prevision Policy Clips | John O'Brien is Senior Adviser to the Secretary for Drug Pricing Reform

FDA Shortage Report To Congress Likely To Reflect National Security Theme For Old Generics: Good Foundation For Price Support Efforts

Prevision Policy Clips | George H. W. Bush’s Legacy For Pharma

GAO Orphan Drug Report Could Fuel Criticism Of Market Incentives; Imbruvica, Avastin Mentioned As Drugs With Multiple Orphan Indications