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 U.S. Food and 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

• All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates have participated, were and, if still pending, are being, conducted in all material respects in accordance with applicable standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable law.

• The Company and its Subsidiaries hold all required governmental authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of the Company as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates.

• Since January 1, 2019, Parent has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or in which Parent or its current products or product candidates have participated.

• Since January 1, 2019, neither the Company nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Company’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries or their respective current products or product candidates have participated.

• Except as disclosed in the SEC Reports, there are no proceedings pending or, to the Company’s knowledge, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug & Cosmetics Act and the FDA regulations adopted thereunder, the Public Health Service Act or any other similar law administered or promulgated by any Drug Regulatory Agency.

More Definitions of Drug Regulatory Agency

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.

Drug Regulatory Agency shall have the meaning given to such term in Section 3.12(c).