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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
DELETE: sample_2.pdf  Centers for Medicare & Medicaid Services (CMS) Proposed
Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned  Food and Drug Administration (FDA) Proposed
Solicitation of New Safe Harbors and Modifications to Existing Safe Harbors  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
DIY Instructions   Centers for Medicare & Medicaid Services (CMS) Proposed
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
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