Information for Health Care Professionals

FAQ: Labeling Requirements Review information about patient labeling, including medication guides, patient package inserts, and instructions for use. FDALabel The FDALabel database offers detailed drug labels for FDA-approved medications, including reported side...

OPDP’s Social Science Research Program

CDER’s Office of Prescription Drug Promotion (OPDP)’s four-person research team investigates issues in direct-to-consumer and health care provider-directed prescription drug promotional communications. The team uses methodologies such as surveys, experimental...

Drug Development & Approval Process

Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). The center’s...

Guidance Documents for Drug Applications

Guidance documents represent the Agency’s current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to...