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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports  Food and Drug Administration (FDA) Proposed
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information  Food and Drug Administration (FDA) Proposed
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs  Food and Drug Administration (FDA) Proposed
E19 OPTIMISATION OF SAFETY DATA COLLECTION  Food and Drug Administration (FDA) Proposed
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs  Food and Drug Administration (FDA) Proposed
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3337 documents.

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