FDA Community-Acquired Bacterial Pneumonia Guidance Includes Early Endpoint, Flexibility on Prior Antibacterial Use

FDA Final Guidance On “Dear Doctor” Letters Includes Samples, Adds REMS Language

Sentinel Pipeline: Xarelto Surveillance Protocol Is New Addition; Saxagliptin Heart Attack Study Next To Report Out

Sentinel Update: FDA Dropping “Mini” From Name, But Scales Back Plans For Surveillance System

Advisory Committee Votes Against Janssen Xarelto for Acute Coronary Syndrome; FDA Likely to Reject Application

Merck Vorapaxar On Track For Approval In Post-MI And PAD Populations; Committee Urges Including Low-Weight Patients

FDA Sees Increase of $91 Million Above FY13 in Appropriations Omnibus; Sequestered User Fees Restored

COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool Qualification Process

Chelsea’s Northera for NOH: History Repeats Itself with Pressure to Approve Squarely on FDA

Janssen Xarelto for ACS: FDA Committee Asked To Define Duration of Therapy; Another Messy Discussion Is Possible

FDA Tips Hand on Social Media Control: Procedural Guidance Suggests Sponsors Will Be Held Broadly Responsible

Merck Vorapaxar Heads to Panel With Positive Primary Review; Statistical Issues Challenging, But Unlikely to Derail Approval

Part D & Prescription Abuse: CMS Proposes Prescriber Enrollment; Encourages Public Review of Claims Data

Antidepressants Face Toughest Challenge in Reversing CMS Proposal on Protected Classes; Process Issues Ripe For Comment

Biopharma Regulatory Prospects for 2014: Good Climate Continues, but NDA Approval Numbers Definitely Past Peak

Chelsea Northera for NOH: A Chance for History To Repeat Itself But FDA Clear Of Its Intention To Reject The Application

CMS Defines “Non-Interference” In Part D Rule; Rx-Friendly Provisions Beyond Protected Class Changes

Pediatric Rare Diseases: Trial Networks, Master Protocols and “Unusual Responders” Get Attention In FDA Workshop Day Two

Advisory Committee Trends: Final Data From 2013 Confirm Challenge For Supplemental NDAs Taken To Panel

FDA Finalizes Drug Development Tools Qualification Guidance; Biomarker “Context of Use” Statement Highlighted

Rare Disease Drug Development: Unique Trial Designs, Per-Person Endpoints Discussed At Workshop

Mental Health, Transplant Drugs Would Lose “Protected” Status In Part D Under CMS Proposal; HIV, Epilepsy, Cancer Spared

Advisory Committee Tracker: January Features Three CV Drugs: Merck’s Vorapaxar, Northera Return and Fourth Xarelto Review

Shining LIGHT on Interim Analyses as the Basis for FDA Action: Orexigen Study Could Become Standard Approach

Salt Drug Substances Naming Guidance Ensures Consistency with USP Policy, But FDA Leaves Room For Exceptions