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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
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Material Threat Medical Countermeasure Priority Review Vouchers - Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Draft Guidance for Industry and Food and Drug Administration Staff   Food and Drug Administration (FDA) Proposed
Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy  Food and Drug Administration (FDA) Proposed
Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Proposed
EDPPPS Proposed Edit Comments Letter V2 - December 2011  Centers for Medicare & Medicaid Services (CMS) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VI GRAS Notices  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 47297 documents.

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