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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug…  Food and Drug Administration (FDA) Final
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff  Food and Drug Administration (FDA) Proposed
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff  Food and Drug Administration (FDA) Final
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
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