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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products  Food and Drug Administration (FDA) Final
FDA Considerations for Recommending Charges for Causing the Introduction of Violative Products into Interstate Commerce  Food and Drug Administration (FDA) Final
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability  Food and Drug Administration (FDA) Final
FDA Oversight of PET Drug Products -- Questions and Answers  Food and Drug Administration (FDA) Final
FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)  Food and Drug Administration (FDA) Final
FDA Regional Implementation Specifications for ICH E2B(R3) Implementation  Food and Drug Administration (FDA) Final
FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)  Food and Drug Administration (FDA) Final
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer  Food and Drug Administration (FDA) Final
FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary   Food and Drug Administration (FDA) Final
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act  Food and Drug Administration (FDA) Final
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