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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Master Protocols for Drug and Biological Product Development  Food and Drug Administration (FDA) Proposed
Major Depressive Disorder: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
M11 Clinical Electronic Structured Harmonised Protocol  Food and Drug Administration (FDA) Proposed
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products  Food and Drug Administration (FDA) Proposed
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability  Food and Drug Administration (FDA) Proposed
M10 BIOANALYTICAL METHOD VALIDATION  Food and Drug Administration (FDA) Proposed
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  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
Dry Eye: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3359 documents.

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