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Informative Interview

Drug Products Applications

Standing Meeting

Proposed Rule New Marketing Pathway for Drug Products

Nonprescription drug product that has an additional condition for nonprescription use (ACNU)

Recent FDA Guidances

Investigating Out-ofSpecification (OOS) Test Results for Pharmaceutical Production.

FDA Guidance, May 2022

Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification

FDA Draft Guidance, May 2022

Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products.

FDA Guidance October 2022

Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA

FDA Guidance, October 2022

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

FDA Draft Guidance, October 2022

Bioanalytical Method Validation and Study Sample Analysis

FDA Guidance, November 2022

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