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HHS Guidance Submissions

HHS Guidance

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
Quality Considerations for Continuous Manufacturing  Food and Drug Administration (FDA) Proposed
Sample formats for Form FDA 356h_2011  Food and Drug Administration (FDA) Proposed
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry  Food and Drug Administration (FDA) Proposed
Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Magnetic Resonance (MR) Coil - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 46923 documents.

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