Department of Health and Human Services June 21, 2011 – Federal Register Recent Federal Regulation Documents
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Amendments to Sterility Test Requirements for Biological Products
The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.
Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues; and Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing the availability of two related draft guidances for industry and FDA staff entitled ``Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.'' These draft guidances provide the Agency's current thinking on approaches for classifying products as drugs and devices, certain additional product classification issues, and the interpretation of the term ``chemical action'' under the FD&C Act.
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