Do You Have Questions for FDA?

Abbreviated New Drug Application (ANDA) or

 Prior Approval Supplement Submissions

Please contact the regulatory project manager assigned to the application:

ANDA: Office of Generic Drugs (OGD) Regulatory Project Manager (RPM)

Multidiscipline prior approval and bioequivalence only supplement: OGD RPM

Labeling Only PAS: OGD Labeling Project Manager

ANDA questions post-approval

Qualified questions may be sent as controls. See Section I(E)(1) of the GDUFA III Commitment Letter for more information.

Send any questions that do not qualify as a control to: DrugInfo@fda.hhs.gov

Bioequivalence inspections

CDER-OSIS@fda.hhs.gov

Comments on guidances and other public documents

Visit Regulations.gov and search for the public docket number associated with the guidance.

Compliance issues

CDERCompliance@fda.hhs.gov

Congressional inquiries

Legislation@fda.hhs.gov

Controlled Correspondence - Product Development before ANDA submission to FDA

GenericDrugs@fda.hhs.gov

Drug Master File (DMF)

Pre-DMF submission:

DMFquestion@fda.hhs.gov

Post-DMF submission: DMFOGD@fda.hhs.gov

Electronic submission or Using eCTD

ESUB@fda.hhs.gov

Fees

CDERCollections@fda.hhs.gov

Firm/FDA Establishment Identifier (FEI)

FDAGDUFAFEIRequest@fda.hhs.gov

Form 483 (facility inspection)

The contact is named on the Form 483.

GDUFA and generic drugs inquiries from a trade association. 

OEPGDUFAII@fda.hhs.gov

GDUFA - general inquiries

AskGDUFA@fda.hhs.gov

Generic drugs – general questions

DrugInfo@fda.hhs.gov

Imports

CDERImports@fda.hhs.gov

Inspection classification letter

The contact is named on the Inspection Classification letter.

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Orangebook@fda.hhs.gov

Patents and exclusivity

CDER-OGDPET@fda.hhs.gov

Pre-ANDA meeting requests

PreANDAhelp@fda.hhs.gov

Pre-Launch Activities Importation Requests (PLAIR)

CDER-OC-PLAIR@fda.hhs.gov

Pre-Operational Review (POR) meeting requests

Headquarter Units or

CDER-OPQ-Inquiries@fda.hhs.gov

Press inquiries

CDERTradePress@fda.hhs.gov

Risk Evaluation and Mitigation Strategies (REMS)

Pre-ANDA submission, submit question via Controlled Correspondence to: genericdrugs@fda.hhs.gov

Post-ANDA submission, contact: REMS Program

Self-Identification of Generic Drug Facilities, Sites and Organizations

AskGDUFA@fda.hhs.gov

User Fees

CDERCollections@fda.hhs.gov

Warning letter

The contact is named on the Warning letter or other correspondence.