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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs: Impurities in Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs: Impurities in Drug Substances: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions  Food and Drug Administration (FDA) Final
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDAs: Stability Testing of Drug Substances and Products  Food and Drug Administration (FDA) Final
ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers  Food and Drug Administration (FDA) Final
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule - Concept Paper  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3355 documents.

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