FDA definition

FDA means the United States Food and Drug Administration and any successor agency thereto.

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FDA means the United States Food and Drug Administration.

FDA means the U.S. Food and Drug Administration or any successor entity.

Examples of FDA in a sentence

Yarrow will have the sole right to determine which Licensed Patent Rights will be included in the Purple Book maintained by the FDA or similar or equivalent patent listing or linking source, if any, in other countries in the Territory for Licensed Products, provided that, Yarrow shall provide prior notices to GenSci, consult with GenSci about the Purple Book listing, and consider GenSci’s comments in good faith.
Notwithstanding the foregoing, if the Purchaser Agent and/or Purchasers have issued a Funding Election Notice, the Company will not be permitted to exercise the Call Option (and no Call Closing Date will occur) during the period commencing on the FDA Approval Date through, and including, the earlier of (a) the Second Purchaser Payment Date and (b) thirty (30) days following the FDA Approval Date.
Emmaus shall notify NIT within five (5) business days of any regulatory actions, notices, or requests from the FDA that would reasonably be expected to adversely impact the NDA’s status.
Following assignment, Emmaus shall promptly submit or update the drug listing information with the FDA reflecting NIT as the labeler and distributor of the Products within the Field in the Territory, consistent with FDA requirements to maintain regulatory compliance.
For clarity, Emmaus, as NDA holder and marketer of an authorized generic thereunder, retains ultimate control over interactions with FDA relating to the NDA and such generic, including post approval changes, supplements, annual reports, and safety reporting, in accordance with applicable law.

More Definitions of FDA

FDA shall have the meaning ascribed to such term in Section 3.1(hh).

FDA means the United States Food and Drug Administration, or any successor agency having the same or similar authority.

FDA means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.

FDA means the United States Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.

FDA shall have the meaning ascribed to such term in Section 3.1(hh). “FDCA” shall have the meaning ascribed to such term in Section 3.1(hh). “GAAP” shall have the meaning ascribed to such term in Section 3.1(h).

FDA means the federal Food and Drug Administration.

FDA means the United States Food and Drug Administration, and any successor agency thereto.