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        Center for Drug Evaluation and Research | CDER

CDER Contact Information

                        
                CDER Formal Dispute Resolution
          The CDER Reference Guide


                CDER Ombuds Home
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          Center for Drug Evaluation and Research | CDER
          CDER Contact InformationCenter for Drug Evaluation and Research | CDER CDER Contact Information
  	
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	E-mail: druginfo@fda.hhs.gov**Other ways to contact us:**

Reference Guide for CDER's main offices and phone numbers
	CDER Ombudsman (If you have a complaint rather than a question)
	Requesting Speakers from CDER**Phone Numbers:**

Main FDA for general inquiries: 1-888-INFO-FDA​ (1-888-463-6332​)
	Drug Information: 301-796-3400​ (8:00 a.m. - 4:30 p.m. Eastern Time)
	To submit a report about an Adverse Drug Reaction: MedWatch: 1-800-FDA-1088​**General inquiries about drug products**

Division of Drug Information
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

**Mailing Address for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)**

**New Drug Applications (NDAs)**
CDER Central Document Room:
FDA/Center for Drug Evaluation and Research (CDER)
Central Document Room (CDR)
5901-B Ammendale Road
Beltsville, MD 20705-1266

**Abbreviated New Drug Applications (ANDAs)**
Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Central Document Room (CDR)
5901B Ammendale Road
Beltsville, MD 20705-1266

**Mailing Address for Therapeutic Biologic License Applications (BLAs)**
CDER Central Document Room:
FDA/Center for Drug Evaluation and Research (CDER)
Central Document Room (CDR)
5901-B Ammendale Road
Beltsville, MD 20705-1266

**Mailing Addresses for Return of Adverse Event Reports to CDER**

**For voluntary reports** from healthcare professionals and consumers:
MedWatch - Central Triage Unit
5600 Fishers Lane
Rockville, MD 20852-9787

**For mandatory reports** from regulated industry and IND reporters:
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, MD 20705-1266

Additional Contact Information

Requesting Speakers from CDER

                                                                                  Content current as of:
      10/01/2020
                  
                   
Regulated Product(s)
		 DrugsCDER Contact Information                
                          

                        CDER Formal Dispute Resolution
          The CDER Reference Guide


                        CDER Ombuds
 
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