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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act)  Food and Drug Administration (FDA) Proposed
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Format and Content of a REMS Document Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics  Food and Drug Administration (FDA) Proposed
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
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