Upon notification of FDA eIND approval from the clinician, BioCryst provided the drug, investigator brochure, drug dosing and preparation instructions, and a sample informed consent form.
Where required and before the start of the study, notification and/or approval of the protocol was also obtained from the relevant local competent authorities, ethics committees and/or institutional review boards in each country.
Notification of all NCI approvals for this study was obtained from IMS, Inc., via email correspondence, on July 29th , 2008
As one of Alibaba's largest investors, Yahoo loudly protested the move, claiming it had not received proper notification of the deal nor granted approval.
Therefore, except of the OA model, no further notification or approval by the Ethics Committee for Animal Research of the Bavarian government was necessary for the mouse studies.
In contrast, pre-market notification or approval is required for use of food contact substances in China and the EU to confirm safety.
As that was the case in this study, no further notification or approval by the Ethics Committee for Animal Research of the Bavarian government was necessary.
Feinstein had described an "emergency meeting" where she was informed that "without prior notification or approval, C.I.A. personnel had conducted a search — that was John Brennan's word," of her staff's computers.
Senator Joseph R. Biden Jr. of Delaware, the senior Democrat on the Foreign Relations Committee, said that the Gore-Chernomyrdin agreement appeared to be an executive understanding that did not require Congressional notification or approval.
