FDA Approval

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. 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. 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.