3/6/2015 | Public Docket | Compounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | Notice of Availability |
2/13/2015 | Draft MOU | Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Better the State of [insert STATE] and the U.S. Food and Drug Administration | Notice of Availability |
2/13/2015 | Draft Guidance | Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice of Availability |
2/13/2015 | Draft Guidance | Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities | Notice of Availability |
2/13/2015 | Draft Guidance | Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application | Notice of Availability |
2/13/2015 | Draft Guidance | Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice of Availability |
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