FDA Law and Regulation definition

FDA Law and Regulation means the provisions of the FD&C Act and all applicable regulations promulgated by the FDA.

FDA Law and Regulation has the meaning set forth in Section 4.28(a).

FDA Law and Regulation means the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. §§ 301 et seq., and all applicable regulations promulgated by the FDA, including but not limited to the recordkeeping provisions of the FDA’s Medical Device Reporting requirements as set forth in 21 C.F.R. Part 803, as applicable.

Examples of FDA Law and Regulation in a sentence

• This group of co-authors was not evident in the co-citation map of authors created form the WoS data for the earlier study (Sinclair 2016) but, as noted above, since the publication of that study WoS has started a specific Chinese Citation Index, and Scopus will have increased its indexing of Chinese research.

• There has not been any material violation of any FDA Law and Regulation or any law or regulation of a comparable foreign regulatory or Governmental Authority by the Company in its product development efforts, submissions, record keeping and reports to FDA or a comparable Governmental Authority that could reasonably be expected to require or lead to investigation, corrective action or enforcement, regulatory or administrative action.

• The Company has not received any notice or communication from the FDA alleging material noncompliance with any applicable FDA Law and Regulation.

• The Company Group has not received any written notice or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation.

• No Loan Party nor any Subsidiary has entered into any consent decree or order pursuant to any FDA Law and Regulation and no Loan Party nor any Subsidiary is a party to any judgment, decree or judicial or administrative order pursuant to any FDA Law and Regulation, except for any decrees, judgments, or orders that could not reasonably be expected to have a Material Adverse Effect.

More Definitions of FDA Law and Regulation

FDA Law and Regulation means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § § 301 et. seq., as amended (the “FD&C Act”), and all applicable regulations promulgated by the FDA.

FDA Law and Regulation means the provisions of the FD&C Act and all applicable regulations or guidance promulgated by the FDA.

FDA Law and Regulation as defined in the preamble to Section 4.29.

FDA Law and Regulation shall have the meaning set forth in Section 3.5(g).

FDA Law and Regulation has the meaning assigned to such term in Section 3.16(a).

FDA Law and Regulation has the meaning set forth in Section 5.28.1.

FDA Law and Regulation means the federal Food, Drug and Cosmetic Act (the FD&C Act), 21 U.S.C. §§ 301 et seq., as amended, and all applicable regulations promulgated by the United States Food and Drug Administration (“ FDA”), including but not limited to the recordkeeping provisions of the FDA’s Medical Device Reporting requirements as set forth in 21 C.F.R. Part 803, as applicable.