CDER Medical Policy Changes: Big Picture Policy Role May Diminish in Favor of Discrete Projects Like Patient Labeling

FDA Committee Reviews REMS Messages For Providers; FDA May Allow Efficacy Discussion To Be Added For “Context”

FDA Structure: Globalized, But De-Centralized Following Departure of John Taylor

FDA-CMS Summit For Biopharma Executives

Limited Population Antibiotic Bill Introduced; Includes Provisions for Use Monitoring, Breakpoints

Bristol/AZ Metreleptin Clears Committee, But Indication Needs Refinement; “Program” NDAs Stay Perfect At Panels

Bristol/AZ Dapagliflozin Clears Committee Second Time Around; Comparative Safety May Be Commercial Risk

Bristol/AZ Dapagliflozin Likely Headed To Approval on Second Review; Case Study In Use Of Dispute Resolution

Takeda’s Vedolizumab: Committee Supports Approval in Crohn’s & UC; Timing Will Depend on Risk Management Plan

Generic Drug “Super Office” Structure Finalized, CDER’s Woodcock Takes Over Outside Quality Function

Bristol/AZ Metreleptin Tests Limits On Rare Disease Flexibility at FDA; Manufacturing Issues Have Implications For Biosimilars

Manufacturing to Front Burner at FDA and Capitol Hill: CDER Director Woodcock Gets Capitol Hill Hearing For FDA’s Quality Control Functions Initiative

Government Responds to Caronia: Issue in Off-Label Marketing Is Not Promotional Speech But “False Claims”

Takeda’s Vedolizumab for Ulcerative Colitis and Crohn’s: PML Safety History Will Be Central to Panel Decision

Advisory Committee Trends: Panels Are Getting Tougher For Supplements; “Program” NDAs Start Strong

CDER Strategic Plan Underscores Agency-Wide Commitment to Improving Management – But Not New Initiatives

FDA Compounding Guidances Update Enforcement Policy, Set Process for “Outsourcing Facility” Registration

FDA Seeking More Control Of Meta-Analyses; PDUFA-Backed Guidance Document Likely To Push Standards, Transparency

Advisory Committee Tracker: Bristol/AZ And Chelsea Hope Second Time’s A Charm With Resubmissions Headed To Panels

Compounding Bill “Outsourcing Facilities” Self-Identification: FDA Enforcement Push in 2013 Should Help

DQSA Senate Floor Statements Re-affirm Repackaging (Avastin), Compounding for Office Use

BioMarin Vimizim Recommended For Approval; Committee Supports Broad Label, FDA Likely To Follow

Compounding/Track and Trace Bill Passes Senate; Next Step is President’s Desk

House FDASIA Hearing Reaffirms CDER’s Special Place on Hill; But No Special Relief for Sequester Problems

FTC Biosimilars Hearing Will Look at Naming, State Substitution Laws; “Orange Book” For Biologics One Idea Raised