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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
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Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities  Food and Drug Administration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Draft Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation  Food and Drug Administration (FDA) Proposed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
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Certain Medicare+Choice Organizations  Office of Inspector General (OIG) Proposed
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Nonproprietary Naming of Biological Products: Update Guidance for Industry  Food and Drug Administration (FDA) Proposed
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