FDA Good Clinical Practices definition
FDA Good Clinical Practices means the standards set forth in 21 C.F.R. Parts 50, 54, 56 and 312 and FDA’s implementing guidance documents.
FDA Good Clinical Practices means the standards set forth in 21 C.F.R. Parts 50, 54, 56, 312, and 314 (and any foreign equivalent) and FDA’s implementing guidance documents (and any foreign equivalent).
FDA Good Clinical Practices means the regulations set forth in 21 C.F.R. Parts 50, 54, 56, 312, and 314, and FDA-adopted International Council for Harmonisation (“ICH”) Good Clinical Practice guidance, including E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1).
Examples of FDA Good Clinical Practices in a sentence
Except as set forth on Schedule 4.19(b) of the Disclosure Letter, any unit of the Product distributed, including for investigational use, or sold in the Territory at all times during the past five (5) years has been manufactured and developed in all material respects in accordance with current FDA Good Manufacturing Practices, FDA Good Clinical Practices and FDA Good Laboratory Practices (as applicable) and no inquiries regarding material issues have been initiated by any competent Governmental Authority.
More Definitions of FDA Good Clinical Practices
FDA Good Clinical Practices means the standards set forth in 21 C.F.R. Parts 50, 56, 312, 314 and 316 (and any foreign equivalents), and as interpreted through FDA’s applicable guidance documents (and foreign equivalents). “FDA Good Laboratory Practices” means the standards set forth in 21 C.F.R. Part 58 (and any foreign equivalents), and as interpreted through FDA’s applicable guidance documents (and foreign equivalents). “FDA Good Manufacturing Practices” means the standards set forth in 21 C.F.R. Parts 210 and 211 (and any foreign equivalents), and as interpreted through FDA’s applicable guidance documents (and foreign equivalents).
FDA Good Clinical Practices means the standards set forth in 21 C.F.R. Parts 50, 56, and 812 (and any foreign equivalents), and as interpreted through FDA’s applicable guidance documents (and foreign equivalents). “FDA Good Laboratory Practices” means the standards set forth in 21 C.F.R. Part 58 (and any foreign equivalent), and as interpreted through applicable guidance documents by FDA (and foreign equivalents). “FDA Good Manufacturing Practices” means the standards set forth in 21 C.F.R. Part 820 (and any foreign equivalents), and as interpreted through applicable guidance documents by FDA (and foreign equivalents). “FDA Laws” means all applicable statutes (including the FDCA and the Public Health Service Act (42 U.S.C. § 262 through § 263) (the “PHSA”), rules and regulations implemented, administered, or enforced by the FDA and any United States state and foreign equivalents, and as interpreted through applicable guidance documents by the FDA (and United States state and foreign equivalents). “FDCA” is defined in Section 4.19(b).