USFDA Guidance: Review of Drug Master Files in Advance of Certain ANDA Submissions
USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
USFDA Guidances: Topical Generic Drug Products - ANDAs
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication