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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff  Food and Drug Administration (FDA) Proposed
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Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators  Food and Drug Administration (FDA) Proposed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Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently…  Food and Drug Administration (FDA) Proposed
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3): Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).”  Food and Drug Administration (FDA) Proposed
Malik: Test  Centers for Medicare & Medicaid Services (CMS) Proposed
DELETE: sample_2.pdf  Centers for Medicare & Medicaid Services (CMS) Proposed
Draft Instructions for Completing the Medicare Advantage Bid Pricing Tools for CY2023  Centers for Medicare & Medicaid Services (CMS) Proposed
Draft Instructions for Completing the Prescription Drug Plan Bid Pricing Tools for CY2023  Centers for Medicare & Medicaid Services (CMS) Proposed
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