Submission of Controlled Correspondence

Generic Drug User Fee Program

OMB: 0910-0727

IC ID: 262988

Documents and Forms

Document Name Document Type
0727 Competitive Generic Therapies Final guidance OCT 2022.pdf Other-Agency Guidance
0727 Cover Letter Attachments for Controlled Correspondence and ANDA Submissions JUNE 2023.pdf Other-Agency Guidance
0727 - CPAs draft guidance SEPT 2022.pdf Other-Agency Guidance
0727 Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA - OCT 2022.pdf Other-Agency Guidance
0727 Controlled Correspondence draft DEC 2022.pdf Other-Agency Guidance
0727 Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.pdf Other-Agency Guidance