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: 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 Patent Certifications and Suitability Petitions FAQs CDER Conversation: Patents and Exclusivities for Generic Drug products Competitive Generic Therapy Approvals	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.

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.