VA Sovaldi Hearing Highlights Transition In Themes: Attacks On Pricing May Yield To Attacks On Price Controls In 2015

FDA Finalizes Pregnancy Labeling Rule; Sponsors Will Have 3-5 Years to Update Existing Labels

Better Than Part D? Biopharma Gets Positive Changes In CMS Proposed Rules for ACA Exchange Plans

Advisory Committee Tracker: Two Very Public Anti-Infective Meetings; One Closed Bone/Reproductive/Urology Session

Track and Trace Guidance Outlines Ways to Exchange Data; Guidance on Standardization and Documentation Still to Come

Epidural Steroid Injection Advisory Committee Leaves FDA with Flexibility on Contraindications

FDA NME “Snapshots” Provide Short-Form Access to FDA Detailed Drug Approval Data and Demographic Profile

Ending "Off-Label" Oncology Use: FDA Testing Streamlined sNDA Reviews; ASCO, Palmetto Setting Up Registries

FDA Updates Compounding Guidances: Product Reporting Goes Electronic; Registration Guidance Clarifies How to De-Register

What Makes A “Breakthrough”? No Bright Line, But 50% Improvement Is Good Marker; FDA Sees Stronger Pipeline

CMS Coverage With Evidence Development Guidance: Update Says CED Could Become More Frequent With Earlier Stage Technologies

Generic Medicaid Rebate Increase Proposed By Senate Democrats; GOP Response Reaffirms Pricing Flexibility In New Political Climate

FDA Prepares Anti-Infective Drugs Advisory Committee For Historic Meeting: Less Data For Unmet Needs Is Focus

NIH Clinical Trials Disclosure Reg Is Work-in-Progress: Trial Results on Unapproved Products Due Within Three Years

FDA Updates Citizen Petition Guidance to Reflect New 150-day Response Deadline And Biosimilar Applications

Gilead Priority Review Voucher Will Benefit From Pending Senate Bill On Ebola; Deal May Help Protect Lead In HCV

Soliris REMS Program Supported By FDA Advisory Committee: Reduced Frequency for MedGuides and Surveys Urged

FDA Sets ANDA Review Priorities: “First Generic” Criteria Are Narrow; More Industry Comment Sought

Pediatric Disease Priority Review Voucher Guidance: FDA Says 50% Of Indication Must Be “Pediatric” To Qualify

FDA Seeking Patient Participation Mechanisms to Incorporate Patients into Drug Development, Review Discussions

Soliris REMS: DSARM Committee To Answer Broader Question If It Isn’t Broken, Should It Be Fixed?

340B "Mega-Reg" Scrapped; Clarity On Drug Discount Program Now Likely Through Guidance in 2015

Generic Concerta Decisions Show FDA Ready To Take Product Actions As Part Of Regulatory Science Initiatives

Epidural Steroid Injections: FDA Seeks Advisory Committee Support for Recent Warning Covering Off-Label Use

Direct-Acting Oral Anticoagulant Review Scorecard: Speed and Predictability Depend on Which Division Takes the Lead