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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act   Food and Drug Administration (FDA) Final
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers  Food and Drug Administration (FDA) Final
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers  Food and Drug Administration (FDA) Final
Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25)  Food and Drug Administration (FDA) Final
Expedited Programs for Serious Conditions––Drugs and Biologics  Food and Drug Administration (FDA) Final
Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications  Food and Drug Administration (FDA) Final
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations  Food and Drug Administration (FDA) Final
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
FDA Animal Products Database Data Entry Form  Food and Drug Administration (FDA) Final
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