“Contingent Approval”? FDA Accelerated Approval Labeling Guidance Would More Explicitly Cite Limits On AA

CMC Postapproval Changes Guidance Aims To Reduce Burden With Fewer Supplements

Biopharma Legislative Update: Part D, Controlled Substances and Antibiotics Highlight New Bills

Gilead Sovaldi Pricing Challenged By House Democrats; Little Impact Beyond More Headlines

PDUFA VI: Looking Ahead to the Next FDA User Fee Law

FDA HIV Patient Voice Report Highlights Informed Consent, Sensitivity to How Treatments and Cure Research Are Described

Senate Health Committee Hearing Focuses On Prescription Abuse, Zohydro; Future Pain-Specific Hearing Likely

CFS/ME Draft Guidance Focuses on Symptom Alleviation; Highlights Areas for Potential Drug Development Tools

Part D “Protected Classes” Stay Protected; CMS Drops Controversial Parts Of Rule, But Fraud Provisions To Proceed

FDA Budget Request Calls For 8% Increase Over FY14: User Fees Make Up Over 90% of New Funds

Medicare To Provide Free Hep C Screening For Baby Boomers (1945-1965) Under Proposed Policy; Timely Boost For Rx

Obama FY15 Budget Proposal Includes Accelerated Donut Hole Closure, Part D Rebates, Other Repeats From FY14

New Neurology Division Acting Director Dunn Brings MS Review Expertise

FDA Response To Caronia Begins With New Reprint Guidance; “Clarifications” Less Important Than Legal Justification

Advisory Committee Tracker: Antibiotic Revival Takes Center Stage In March With Cubist, Durata Reviews

Rx Counterfeits: House Hearing Shows Bipartisan Support for Stronger Enforcement and Legislative Fixes Down the Road

OTC Epinephrine: Panel Votes Against Approval of Primatene HFA and For Removal of Bulb Nebulizers from Monograph

Part D “Protected Class” Changes Draw Bipartisan Opposition; Antipsychotic Prescribing Controls May Be Alternative

Fibromyalgia Treatment Beyond Pain Is One Likely Topic For Patient-Focused Meeting March 26

Nonprescription Drugs Panel Likely to Recommend Removal of OTC Bulb Nebulizer Bronchodilators from Monograph

CMS Draft Call Letter Proposes Strengthening Opioid Overutilization Policy; Protected Class Proposal Absent

OTC Drug Monograph Modernization Project Announced By FDA, Joining Previous Effort to Broaden OTC Category

FDA Raises Exclusivity For Combos; Won’t Affect Old Products, 2014 Approvals, But Improves Climate For Hep C Therapies

FDA, DEA Controlled Substances Policy Continues To Attract Legislative Interest; Potential Changes In PDUFA VI?

Primatene HFA OTC Inhaler Heads to Advisory Committee; Primary Issue is Device Performance