CDER News

Testosterone Gel Safety Information

Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide

Guidance for Industry

Comprehensive List of Guidance Documents

Guidance for Industry

New Revised/Withdrawn List for 2009

Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic

BRisk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic

Division of Drug Marketing, Advertising, and Communications: Presentations

Division of Drug Marketing, Advertising, and Communications: Presentations (updated)

FDA has approved pancrelipase (Creon Delayed-Release Capsules)

FDA has approved pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency

FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic and Myobloc (

FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

Guidance for Industry

Label Comprehension Studies for Nonprescription Drug Products

Manual of Policies and Procedures (MaPP)

Scientific Interest Groups: Criteria and Policies

Manual of Policies and Procedures (MaPP)

Scientific Interest Groups: Criteria and Policies

Syndicate content