FDA Good Clinical Practices definition

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 standards set forth in 21 C.F.R. Parts 50, 56, 312, and 314 (and any foreign equivalents) and FDA’s implementing guidance documents.

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

• This study will be conducted in accordance with current U.S. Food and Drug Administration (FDA) Good Clinical Practices (GCPs), and local ethical and legal requirements.

• Awardee will reasonably cooperate with NINDS to accommodate a Third Party’s need to audit raw data and source documents to the extent necessary to verify compliance with FDA Good Clinical Practices and the protocol.

• Except as set forth on Schedule 4.6(o) of the Disclosure Letter, to the Knowledge of Parent, at the time of any shipment of any Product occurring prior to the applicable Closing Date, the units thereof so shipped complied in all material respects with their relevant specifications and were developed and manufactured in accordance in all material respects with current FDA Good Manufacturing Practices, FDA Good Clinical Practices, and FDA Good Laboratory Practices.

• NCI clinical trials must be conducted in accordance with the FDA Good Clinical Practices (GCP).

• T rippBio plans to immediately implement a clinical program (conducted under U.S. FDA Good Clinical Practices) to determine the efficacy of T D213 to treat COVID-19 patients.

• This study will be conducted in accordance with current FDA Good Clinical Practices (GCPs), and local ethical and legal requirements.

• This study will be conducted in accordance with current U.S. Food and Drug Administration (FDA) Good Clinical Practices (GCPs), the Declaration of Helsinki, and local ethical and legal requirements.

• The general scope of such visits would be to inspect study data (regulatory requirements), source documentation and CRF completion in accordance with current FDA Good Clinical Practices (GCP), the ICH guidelines and the respective local and national government regulations and guidelines.

• Auditing will comply with the DCTD guidelines as described on the CTEP website at: xxxx://xxxx.xxxxxx.xxx/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm NCI clinical trials must be conducted in accordance with the FDA Good Clinical Practices (GCP).

• NCI will ensure that Clinical Studies must be conducted by Approved Investigators in accordance with the FDA Good Clinical Practices (GCP) and, if required by the applicable Proposal, Non-Clinical Studies must be conducted in accordance with the FDA Good Laboratory Practices (GLP).

More Definitions of FDA Good Clinical Practices

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).