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HHS Guidance Submissions

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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
Public Availability of Labeling Changes in "Changes Being Effected" Supplements  Food and Drug Administration (FDA) Proposed
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex  Food and Drug Administration (FDA) Proposed
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q1B Photostability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50101 documents.

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