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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs): Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Supplementing the Guidance Provided in the Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
This Guidance Portal contains 46923 documents.

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