Sec. 105. Guidance on changes to an approved application for biological products
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Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final guidance that— addresses changes in a licensed biological product or the labeling, production process, quality controls, equipment, facilities, or responsible personnel for such a product established in the application for the product that was approved under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); does not address such changes for specified biotechnology or specified synthetic biological products listed in section 601.2(c) of title 21 of the Code of Federal Regulation; and updates and supersedes the guidance entitled Changes to an Approved Application:
Biological Products, that was issued by the Food and Drug Administration in July, 1997.
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Sec. 105
Guidance on changes to an approved application for biological products
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