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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Postapproval Pregnancy Safety Studies Guidance for Industry   Food and Drug Administration (FDA) Proposed
Pre-Launch Activities Importation Requests (PLAIR)  Food and Drug Administration (FDA) Proposed
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers  Food and Drug Administration (FDA) Proposed
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Submissions in Electronic Format — Postmarketing Safety Reports  Food and Drug Administration (FDA) Proposed
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