FDA Announces Public Hearing on “Safe Use Conditions” to Expand OTC Category: Implications for Statins, Asthma Drugs

Forest Survives Context Review: Aclidinium Gets Approval Vote for COPD; Next Step Is Post-Market Discussions

Chelsea’s Northera: FDA Panel Overrules Reviewers But Another Study May Be Necessary Anyway

Drug Review Dossier: IPX066

Forest Aclidinium Mid-Day Update: Key Issue Is Whether Database Measures Up to Prior Sponsors in the Class

Qnexa Gets To Yes: Vivus Weight Loss Drug Clears Advisory Committee; Outcomes Discussion Still Looms

Qnexa Mid-Day Update: Is Imperfect REMS Good Enough For Vivus Weight Loss Drug?

FDA Drug Shortage Guidance Emphasizes Sponsor Responsibility, Awareness of Market

Forest Aclidinium Cardiovascular Safety Signal is “Uncertain”: FDA Experience with COPD Class Calls for Caution But Bodes Well for Pending NDA

Chelsea Therapeutics’ Northera: Short Efficacy Period, Safety Risks Outweigh Medical Need

Vivus Qnexa Advisory Committee Preview: Risk Management Unsettled, CV Outcomes Vote Provisional

TREAT Act Introduced; Focuses on Accelerated Approval, Emphasis on Innovation and Patient Involvement

Weight Loss Drugs, Round Two: Approvals in 2012 Unlikely; Outcomes Standards May Favor Vivus’ Qnexa

Drug Review Dossier: tafamidis meglumine

President’s FY 2013 Budget Released – No Surprises for FDA

Just Say No: 2012 Committee Votes Reinforce Changing Significance of Panel Reviews

FDA Biosimilar Guidances Released: A Long Short-Cut Described

Drug Shortages Dominate Generic/Biosimilar User Fee Hearing

Eisai’s Dacogen For AML: Panel Votes Down New Indication As Follow-Up Analysis Is Not Enough

Drug Review Dossier: crofelemer

Amgen Xgeva Label Expansion Rejected By FDA Committee: New Study Needed For Approval

Drug Review Dossier: pertuzumab

Eisai/Astex Dacogen Faces Tough Committee Review: Expanded Use Likely To Need New Study

Drawing the Line on Line Extensions: Further Thoughts on Medicaid Rebate Proposed Rule

Xgeva Label Expansion: Key Issue for Advisory Committee Will Be Role of Early vs. Late Use of Amgen Bone Drug in Prostate Cancer