Additional Contacts - CDER:

Controlled Substance Staff

• Division of Drug Information

Division of Pediatric and Maternal Health

• Pediatric
• Maternal Health

Enhanced Communication Team

• ONDEnhancedComm@fda.hhs.gov

Import/Export

• General Imports Compliance
• Export Certificate and Compliance

Ombudsman

• CDERombudsman@fda.hhs.gov

Rare Diseases Program

• Small Business & Industry Assistance Program

Additional Contacts: CBER

Manufacturers Assistance and Technical Training Branch

• industry.biologics@fda.hhs.gov

Ombudsman

• cberombudsman@fda.hhs.gov

Additional Contacts: Misc.

Office of Special Medical Programs

• TBD

Advisory Committee Oversight and Management Staff

• TBD

Office of Combination Products

• combination@fda.gov

Office of Good Clinical Practice

• gcp.questions@fda.hhs.gov

Office of Orphan Products Development

• orphan@fda.hhs.gov

Office of Pediatric Therapeutics

• OPT@fda.hhs.gov