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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Potency Assurance for Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products  Food and Drug Administration (FDA) Proposed
Drug Master Files Guidance for Industry  Food and Drug Administration (FDA) Proposed
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) 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Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not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
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
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