U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Resources for You | Drugs
  4. Information for Industry | Drugs
  1. Resources for You | Drugs

Information for Industry | Drugs

Topics on this page

Guidance, Compliance, and Regulatory Information


Drug Application Forms, Submission Requirements, and User Fees

Drug Approvals and Databases

Drug Development and Approval Process

Drug Quality and Manufacturing

Drug Information, Safety, and Availability

CDER Small Business and Industry Assistance

Can’t find what you are looking for? Contact the CDER SBIA staff
(866) 405-5367(301) 796-6707CDERSBIA@fda.hhs.gov
CDER SBIA Office of Communications 10001 New Hampshire Avenue Hillandale Building, 4th Floor Silver Spring, MD 20993

About FDA and CDER