FDA definition
Examples of FDA in a sentence
RELEASE OF NEWBORN STEM CELLS other treatment, or a study pursuant to a FDA or an IRB approved protocol.
With respect to any food shipment for which a prior notice confirmation number (“PN Number”) is required to be provided to the Bureau of Customs and Border Protection (“CBP”), FDA, or any other government agency upon arrival, it shall be the responsibility of Cargo Interests to ensure that such PN Number has been provided to the required agencies and other persons prior to vessel arrival.
The Properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA.
The research to be conducted involves human tissues within the meaning of 45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56, and FDA Good Clinical Practice Guidelines (ICH E6 Good Clinical Practice: Consolidated Guidance, 62 FR 25692 (1997)) and may be subject to The Privacy Act of 1974, as amended, at 5 U.S.C. §552a (“Privacy Act”) as is the case of the Consortium SAMPLES provided by a federal laboratory; all research to be performed hereunder must comply with the requirements contained therein as applicable.
The Company has not received any notice or other communication from the FDA or any other Governmental Authority alleging any violation of any applicable Health Care Law with respect to such activities.