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: [email protected] Quality only PAS: [email protected]
ANDA questions post-approval	[email protected]
Bioequivalence inspections	[email protected]
CMC requirements and post-approval change reporting categories	[email protected]
Comments on guidances and other public documents	Visit Regulations.gov and search for the public docket number associated with the guidance.
Compliance issues	[email protected]
Congressional inquiries	[email protected]
Controlled Correspondence - Product Development before ANDA submission to FDA	[email protected]
Drug Master File (DMF)	Pre-DMF submission: [email protected] Post-DMF submission: [email protected]
Electronic submission or Using eCTD	[email protected]
Fees	[email protected]
Firm/FDA Establishment Identifier (FEI)	[email protected]
Form 483 (facility inspection)	The contact is named on the Form 483.
GDUFA and generic drugs inquiries from a trade association.	[email protected]
GDUFA - general inquiries	[email protected]
Generic drugs – general questions	[email protected]
Imports	[email protected]
Inspection classification letter	The contact is named on the Inspection Classification letter.
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations	[email protected]
Patents and exclusivity Patent Certifications and Suitability Petitions FAQs CDER Conversation: Patents and Exclusivities for Generic Drug products	[email protected]
Pre-ANDA meeting requests	[email protected]
Pre-Launch Activities Importation Requests (PLAIR)	[email protected]
Pre-Operational Review (POR) meeting requests	Headquarter Units or [email protected]
Press inquiries	[email protected]
Risk Evaluation and Mitigation Strategies (REMS)	Pre-ANDA submission, submit question via Controlled Correspondence to: [email protected] Post-ANDA submission, contact: REMS Program
Self-Identification of Generic Drug Facilities, Sites and Organizations	[email protected]
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.