Create Account

Organization Type

NOTE: Existing CDER Direct users do not need to create a new account. Existing accounts can be converted to a Combined account, by going to 'EDIT USER PROFILE' after logging to your existing account.

What type of Account are you creating ?

CDER Direct

Cosmetics Direct

Combined (CDER Direct and Cosmetics Direct)

There are three types of account that can be created on FDA Direct: CDER Direct, Cosmetics Direct, and a combined account (CDER Direct & Cosmetics Direct). A combined account is intended for companies that have both drugs and cosmetics submissions. A combined account streamlines both drugs and cosmetics submission requirements and saves time and effort. DUNS number is only a required field if you create a CDER Direct account or a combined account (CDER Direct and Cosmetics Direct). DUNS number is NOT required but requested if you create only a Cosmetics Direct account.

Organization Information

Name: *

DUNS: *

Organization Address

City: *

State: *

Contact Information

Contact Phone

Phone Extension:

Form Access

ESTABLISHMENT REGISTRATION AND DRUG LISTING

ESTABLISHMENT REGISTRATION
NDC LABELER CODE REQUEST
DRUG LISTING AND CERTIFICATION

BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING
BULK INGREDIENT
CELLULAR THERAPY
DRUG FOR FURTHER PROCESSING
HUMAN OTC DRUG LABEL
HUMAN PRESCRIPTION DRUG LABEL
NON-STANDARDIZED ALLERGENIC LABEL
PLASMA DERIVATIVE
STANDARDIZED ALLERGENIC
VACCINE LABEL

NDC RESERVATION

COSMETIC REGISTRATION AND LISTING

REGISTRATION OF COSMETIC PRODUCT FACILITY
COSMETIC PRODUCT LISTING

DRUG REPORTING BY OUTSOURCING FACILITY

OUTSOURCING FACILITY REGISTRATION
COMPOUNDED DRUG REPORTING

DSCSA ANNUAL REPORTING

WHOLESALE DRUG DISTRIBUTOR AND THIRD-PARTY LOGISTICS PROVIDER REPORTS

GENERIC DRUG SELF-IDENTIFICATION

GENERIC FACILITY GDUFA SELF-IDENTIFICATION

Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.

I have read and agree to the Terms and Conditions stated above.