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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postapproval Changes to Drug Substances Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents: Draft…  Food and Drug Administration (FDA) Proposed
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed
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