Drug Competition Workshop Illuminates Strengthening FDA-FTC Partnership; “One Common Drug Master File” REMS Guidance Aims To Stop Abuses

Prevision Policy Clips | Republican Congressmen Request Delay in Signing of NDAA Conference Report

Allergan-Mohawk Restasis Deal Questioned By House Judiciary; Legislation Could Change Patent Review Process

Combination Products At FDA: A Good Time For Industry To Engage

Generic Controlled Correspondence Guidance Includes Timelines, Specifics On “Complex” Issues Category

Pfizer Staph Vaccine: FDA Advisory Committee Gives Qualified Support To Clinical Development Based On One Type of Surgery; Enough To Keep Moving

Prevision Policy Clips | Drug Master File for Shared System REMS Submissions Draft Guidance Part Of FDA Competition Strategy

The Last Word On Hepatitis C? FDA Finalizes Drug Development Guidance After Period Of Dramatic Change

Prevision Policy Clips | Ionis Submits Inotersen NDA for Treatment of Hereditary TTR Amyloidosis

Going Solo: Combo Products Hearing To Look At Devices Pursuing New Uses Drug Sponsors Don’t Want

MedPAC Supports Applying “Donut Hole” Discount to Biosimilars; Wants To Do More On Biosimilar Barriers and Drug Pricing Overall

Office Of New Drugs Overhaul May Include Disease-Specific Offices; Will Post-Market Safety Be Reintegrated With Pre-Market Review?

Prevision Policy Clips | FDA Commissioner Gottlieb to Enhance Medical Product Review Process Through Organizational Changes

Prevision Policy Clips | “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications” Draft Guidance Available

Part B and Biosimilars: CMS Goes With Competition Argument For Separate Biosimilars Codes

Who You Gonna Call? FDA Developing Webpage To Channel Patient Engagement Inquiries On Drug Development Projects

CMS Finalizes Payment Cut For 340B Drugs At ASP-22.5%; Impact Mostly On Hospitals, But Newly Launched Drugs Could Benefit

Biosimilars Will Be Paid Separately Under Medicare In 2018; CMS Previews Upcoming Change In Hospital Outpatient Rule

Prevision Policy Clips | Generic Drug Development Controlled Correspondence Draft Guidance

White House Opioid Final Report Hits Payors Hard For Coverage Gaps; FDA Faulted For “Inadequate Oversight”

Braeburn Injectable Buprenorphine Clears FDA Committee; Need For New Addiction Treatments Carries The Day, Despite Unclear Dose Data

Indivior’s Buprenorphine Injection Clears Advisory Committee; Role for Higher Dose Unclear

Prevision Policy Clips | FDA “Assessment of FDA Hiring and Retention” Public Meeting Scheduled for November 30

Protecting Orphan Drug Act Is NORD’s Policy Priority For 2018; Campaign To Counter “Misinformation” About Incentives

ACA Exchange Rule Promises “Future” Policies On Drug Costs; Immediate Impact May Be More Restrictive Plans