Drug Regulatory Agency definition

Drug Regulatory Agency has the meaning set forth in Section 2.12(c).

Drug Regulatory Agency means the FDA or other comparable governmental authority responsible for regulation of the research, development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products and drug product candidates.

Drug Regulatory Agency means the United States Federal Drug Administration (“FDA”) or other foreign, state, local or comparable governmental authority responsible for regulation of the research, development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or biological products and drug or biological product candidates.

Examples of Drug Regulatory Agency in a sentence

• Each of Apricus and Merger Sub is in compliance in all material respects with the Apricus Regulatory Permits and neither Apricus nor Merger Sub has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Apricus Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Apricus Regulatory Permit.

• Since January 1, 2015, neither Apricus nor Merger Sub has received any written notices or correspondence, or other written communications from any Drug Regulatory Agency requiring or, to the Knowledge of Apricus, threatening to initiate, the termination, suspension or material modification of any clinical studies conducted by or on behalf of, or sponsored by, Apricus or in which Apricus or its current products or product candidates, including the Apricus Product Candidates, have participated.

• The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit.

• Since the Company’s incorporation, the Company has not received any written notices or correspondence, or other written communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated.

More Definitions of Drug Regulatory Agency

Drug Regulatory Agency has the meaning set forth in Section 3.08(c).

Drug Regulatory Agency has the meaning set forth in Section 4.20(a).

Drug Regulatory Agency means in the United States, the FDA or any successor US federal agency having responsibility over Regulatory Approval, and in countries other than the United States, the applicable governmental or regulatory authority having jurisdiction over the approval of sale of Product in any particular country or region in the Territory (for example, the European Medicines Evaluation Agency for the European Union).

Drug Regulatory Agency means the United States Food and Drug Administration (FDA) or other comparable governmental authority responsible for regulation of the research, development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products and drug product candidates.

Drug Regulatory Agency has the meaning set forth in Section 3.13(b) of the Agreement.

Drug Regulatory Agency means the EMA, FDA or any other federal, state, local or non-U.S. governmental entity that is concerned with the safety, efficacy, reliability, manufacturing, labeling, marketing, or advertising of drug products.

Drug Regulatory Agency means the FDCA, the PHSA, FDA regulations adopted thereunder, or any other similar Law promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products.