FDA Approval

FDA Approval. Means written authorization from the US Food and Drug Administration for the Company to commence commercial sale of a Covered Product in the United States.

FDA Approval. Shall mean, with respect to an Agreement Product, receipt by Genzyme of an approval letter from the FDA to promote, market, distribute and sell such Agreement Product in the Territory.

FDA Approval. The Company's receipt of marketing approval in the United States (including "accelerated approval" in accordance with 21 C.F.R. §314.500 et seq.) from the U.S. Food and Drug Administration on or before December 31, 2012, for a new drug application submitted by the Company as sponsor and relating to the Company's Marqibo (vincristine sulfate liposomes injection) product candidate.

FDA Approval. Means clearance for marketing by the FDA under Section 510(k) of the Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E, or FDA premarket approval granted in accordance with 21 U.S.C. § 360e and 21 C.F.R. Part 814.

FDA Approval. Final approval or clearance by the FDA through a premarket approval application (PMA), 510(k) premarket notification (PMN), or other applicable regulatory pathways which are now or may become available to market and sell the Testing Services for commercial purposes in the United States for use with regard to humans. For purposes of clarification, FDA Approval shall not include a laboratory's provision of services pursuant to its CLIA license.

FDA Approval. The obtaining of Marketing Approval from the FDA for any Collaboration Product

FDA Approval. The approval of the new drug application (NDA) for the Finished Product by the Food and Drug Administration in the United States of America (FDA).

FDA Approval. The Company's New Drug Application for HEPZATO is approved by the FDA.

FDA Approval. The approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Product in the United States

FDA Approval. Means FDA approval of the NDA Manufacturing Supplement for the Facility.