Minimal Manipulation GUIDANCE FOR FOOD AND DRUG ADMINISTRATIVE STAFF We, FDA, are providing you, human cells, tissues, and cellular and… Read More >
We, the Center for Biologics Evaluation and Research (CBER)1 at the FDA, are issuing this guidance to provide you, tissue… Read More >
Deviation Reporting for HCT/Ps under PHS Act and 21 CFR 1271 GUIDANCE FOR INDUSTRY We, the Food and Drug Administration… Read More >
Revised Eligibility Guidelines: Donors of Human-Derived Clotting Factors GUIDANCE FOR INDUSTRY This guidance provides you, establishments that make donor eligibility… Read More >
GUIDANCE FOR INDUSTRY We, FDA, are issuing this guidance to provide establishments1 that manufacture human cells, tissues, and cellular and… Read More >
GUIDANCE FOR INDUSTRY We, FDA, are providing you, establishments that make donor eligibility determinations for donors of human cells, tissues… Read More >
GUIDANCE FOR INDUSTRY We, FDA, are issuing this guidance to provide you, establishments that manufacture human cells, tissues, and cellular… Read More >
GUIDANCE FOR INDUSTRY This guidance provides you, an establishment1 that makes donor eligibility determinations for certain human cells, tissues, and… Read More >
GUIDANCE FOR INDUSTRY The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the… Read More >