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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001  Food and Drug Administration (FDA) Proposed
Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Drugs  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin  Food and Drug Administration (FDA) Proposed
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation  Food and Drug Administration (FDA) Proposed
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs  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
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