FDA Laws definition
FDA Laws means all applicable statutes, rules, regulations and orders administered or issued by the FDA, including without limitation, the FD&C Act and its implementing regulations.
FDA Laws means all applicable statutes, rules, regulations, standards, guidelines, policies and orders and Requirements of Law administered, implemented, enforced or issued by FDA or any comparable governmental authority.
FDA Laws means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and its implementing regulations and guidance documents and the Public Health Service Act (42 U.S.C. § 201 et seq.) and its implementing regulations and guidance documents.
Examples of FDA Laws in a sentence
The Group Companies and its representatives have not committed any violation of applicable Law, including FDA Laws, that would reasonably be expected to serve as a basis for exclusion, debarment, suspension, or other ineligibility by any Governmental Authority, including the OIG or FDA.
No Group Company is subject to any obligation arising under an investigation, inquiry, or administrative, regulatory or judicial action, hearing, or enforcement proceeding by or on behalf of the FDA, warning letter, untitled letter, FDA Form 483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws, and no such obligation has been threatened in writing.
More Definitions of FDA Laws
FDA Laws means all applicable statutes (including the FDCA), rules and regulations implemented administered or enforced by the FDA (and any foreign equivalent).
FDA Laws has the meaning set forth in Section 4.8.
FDA Laws means the FDCA, the Public Health Service Act, CLIA, Controlled Substances Act and, for each of the foregoing, all comparable state Legal Requirements and the rules and regulations promulgated thereunder by FDA and any other comparable Governmental Entities.
FDA Laws means all applicable statutes, rules, regulations, and orders and Requirements of Law administered, implemented, enforced or issued by FDA.
FDA Laws means all federal, state, local and other applicable jurisdiction Laws relating to the use, manufacture, packaging, licensing, labeling, distribution, or sale of any food, drug, cosmetic, medical device or household product or material.
FDA Laws means all applicable Laws, regulations, and guidance administered or issued by FDA with jurisdiction over medical products, including where applicable, but not limited to (A) the FDCA, (B) FDA requirements and guidance for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, and guidance documents that were issued by the FDA, (C) FDA requirements and guidance for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in the applicable parts of the Code of Federal Regulations and (D) guidance documents that are issued by the FDA.
FDA Laws means all Laws applicable to the operation of the Company’s business related to the research, investigation, development, production, marketing, distribution, storage, shipping, transport, advertising, labeling, promotion, sale, export, import, use handling and control, safety, efficacy, reliability or manufacturing of medical devices, including (i) the Federal Food, Drug, and Cosmetic Act of 1938, as amended (21 U.S.C. §§ 321 et seq.); (ii) the Public Health Service Act of 1944; (iii) the rules and regulations promulgated and enforced by the FDA thereunder, including, as applicable, those requirements relating to the FDA’s Quality System Regulation at 21 C.F.R. Part 820, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), investigational use, premarket notification and premarket approval and applications to market new medical devices; (iv) Laws governing the development, conduct, monitoring, subject informed consent, auditing, analysis and reporting of clinical trials and non-clinical studies (including the GCP and GLP regulations contained in 21 C.F.R. Parts 11, 50, 54, 56, 58 and 812); (v) Laws governing data-gathering activities related to the detection, assessment, and understanding of adverse events (including adverse event and malfunction reporting regulations of FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)); and (vi) all comparable state, federal or foreign Laws related to any of the foregoing.