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Points of Contact for Questions Related to Generic Drugs

Points of Contact for Questions Related to Generic Drugs

Most questions related to generic drugs and GDUFA can be answered through the resources provided at these web pages on FDA.gov: Generic Drugs Program and Generic Drug User Fee Amendments (GDUFA). In addition, the specific topics below are hyperlinked directly to guidances or other helpful information on the FDA website. If you cannot find the information you are seeking, please reach out to the listed FDA point of contact.

Topic

FDA Point of Contact

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: CDERSBIA@fda.hhs.gov

Quality only PAS: CDERSBIA@fda.hhs.gov

 

ANDA questions post-approval

DrugInfo@fda.hhs.gov

Bioequivalence inspections

 

CDER-OSIS@fda.hhs.gov

CMC requirements and post-approval change reporting categories

CDER-OPQ-Inquiries@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

CDERImportsExports@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

Patent Certifications and Suitability Petitions

FAQs

CDER Conversation: Patents and Exclusivities for Generic Drug products

 

 

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

Warning letter

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

Additional resources and information can be found on the following Web pages:  Generic Drug Development, the Office of Generic Drugs, the Office of Pharmaceutical Quality, and the Office of Regulatory Affairs.