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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for Industry  Food and Drug Administration (FDA) Final
"Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications"  Food and Drug Administration (FDA) Final
(Potassium Iodide) KI in Radiation Emergencies-Questions and Answers  Food and Drug Administration (FDA) Final
1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers  Food and Drug Administration (FDA) Final
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day  Food and Drug Administration (FDA) Final
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
2011 POS File  Centers for Medicare & Medicaid Services (CMS) Final
2012 POS File  Centers for Medicare & Medicaid Services (CMS) Final
2013 POS File  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3340 documents.

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