FDA Breakthrough Process Emphasizes Importance of First Meeting with Sponsors: Early Discussions on Manufacturing

White House Pushing New Antimicrobial Resistance Strategy: FDA and NIH Active In Advance of Upcoming Report

Generic Drug Application User Fees Will Be Lower in FY 2015; PDUFA Fees Will Increase By Roughly the Same Amount

LDT Oversight A Victory For Drug Developers But FDA Will Take Time To Take Unapproved Tests Off The Market

Baxter/Halozyme HyQvia Gains Strong Panel Support, Despite Skeptical Review; Eprex Immunogenicity Scare Lingers At FDA

FDA Finalizes Companion Diagnostics Guidance: Keeps “No Surprises” Promise

BioMarin Priority Voucher Sale To Regeneron Demonstrates A Model For Future Market

Advisory Committee Tracker: CV Combos and CV Risk Highlight New Meetings For Fall

IRS Regulations on Branded Prescription Drug Fee Hold To Narrow “Orphan Drug” Interpretation

First Biosimilar Application Disclosed: FDA Has Early 2015 Deadline To Resolve Naming, Labeling Issues For New Category

Defining “Personalized Medicine” May Be Key First Step To Incentives; FDA Wary Of Constraints But Eager For Resources

Tax Inversions: Senate Finance Committee “Must Respond” But No Legislative Path Forward At Present

House Hearing Features Indirect Approaches To Reforming FDA Off-Label Policy; Data “Qualification” As Alternative To New Rules?

Track & Trace Guidance: Scenarios to ID Suspect Products, How to Terminate Notifications of Illegitimate Products

340B Orphan Drug Rule Published; Sets Stage For Next Round Of Litigation

Office of Pharmaceutical Quality Still Set For September Kick-Off As FDA Finalizes OGD “Super Office”

21st Century Cures Tech Hearing: Pharma Highlighted For Savvy IT Use, Potential Beneficiary Of Proposed Improvements

Informed Consent Guidance Demonstrates FDA’s Developing Insight into Complicated Research Populations

FDA Position On Testosterone CV Risk Outlined In Petition Denial; 800-Patient “T-Trial” Results In 2015 Will Be Key

Senate Finance Committee Chronic Health Conditions Hearing Focuses on Care Coordination, Better Reimbursement Incentives

ANDA Amendments, Prior Approval Supplement Rules Clarified in FDA Draft Guidances; Preparing for GDUFA FDA Performance Targets

340B Orphan Drug Exclusion “Interpretive Rule” Will Be “Binding” For Drug Manufacturers

FDA Patient-Input Activities Praised At July 11 House Hearing: Duchenne Guidance, CF Outcome Measure Are New Proposals

Senate Finance Committee Investigation On Sovaldi Pricing Increases Political Attention But Still No Legislative Strategies

Social Media Guidances Webinar: FDA Reinforces Key Concepts, Will Use Outside Parties For Monitoring