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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements  Food and Drug Administration (FDA) Final
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)  Food and Drug Administration (FDA) Final
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
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
Withdrawn Guidances (Biologics)  Food and Drug Administration (FDA) Final
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry  Food and Drug Administration (FDA) Final
Bioresearch Monitoring Technical Conformance Guide  Food and Drug Administration (FDA) Final
Guidelines for Achieving Compliance with Medicaid and CHIP Eligibility Renewal Timeliness Requirements Following the Medicaid and CHIP Unwinding Period  Centers for Medicare & Medicaid Services (CMS) Final
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