Track-and-Trace Deliverables: FDA Lays Out Specific Action Dates

“Protected Class” Changes May Not Survive; House Hearing Will Showcase Industry/Plan Opposition to Part D Changes

Track-and-Trace Update: FDA Opens Public Docket With Broad Questions For Stakeholders

FDA Releases FY 2012 PMR/PMC Data; FDA’s Jenkins Previewed the Data, Saying Industry Is Meeting Commitments

Pulmonary Arterial Hypertension FDA Patient Meeting: First for Cardio-Renal; Condition With Recent Approvals and Symptom Measures

FDA Wants IoM Help Communicating “Uncertainty” In Risk/Benefit Decisions; Safety Still Main Focus

TMC’s Cangrelor: Advisory Committee Votes Down Dual PCI/Bridge Indications With Few Signals Of A Path Forward

Naproxen Will Not Get Comparative Safety Labeling Advantage; Meta-Analysis Is Not Enough For FDA or Advisory Committees

Sickle Cell Patient Meeting: FDA Seeks Information on Iron Chelators, Hydroxyurea, Potential PROs

House Drug Shortage Hearing Focuses on Long-Standing Shortages, Expediting Reviews, and Inspections

GAO Shortage Report Offers Little Support For Reimbursement Changes; “Economic Factors” Described, Not Emphasized

TMC’s Cangrelor Faces Negative FDA Reviews For PCI & “Bridge” Indications; Positive Panel Vote Still Possible, But Unlikely

340B Update: Contract Pharmacy In Compliance Spotlight; “Wait-and-See” Attitude Likely To Continue In Congress

Naproxen To Get Up or Down Vote on CV Advantage; No Voting Question on Halting Of PRECISION Celebrex Trial

FDA Issues Broad Analgesic Drug Guidance: From Post-Market Requirements for Opioids to Study Plans for Specific Pain Indications

FTC Biosimilars Workshop Underscores Importance of First FDA Biosimilar Approval To Clarify Unsettled Policy Questions

CDER Gets Clear Control of Drug Compliance Policy and Enforcement Strategy As Result of Agency-wide Alignment

GAO Drug Shortage Report Will Be Released Feb. 10; Key Test Of Potential For Changing Generic Reimbursement

HHS Inspector General FY 2014 Agenda Includes Part B Prices, Compounding, Generic Drug Inspections, and 340B

FDA NSAID Review: Headlines Focus on Naproxen CV Advantage, But Real Debate Is Future of Pfizer’s Celebrex

Biosimilar Interchangeability, Social Media Guidances Highlight 2014 Drug Center Agenda

Advisory Committee Tracker: Serelaxin, Cangrelor, NSAID Safety Continue Cardiovascular Focus Of Early 2014 Panels

Waxman Retires; May Take Part D Rebates As Headline Issue With Him

Advisory Committee Supports Approval of Merck’s Ragwitek, Ragweed Allergy Immunotherapy Product

Ragwitek Advisory Committee Preview: Studies Met Primary Endpoint, No Treatment-Related Serious Adverse Events