Examples of FDA Meeting in a sentence
FDA Meeting Notification No later than 10 business days prior to the scheduled meeting The contractor shall forward the dates and times of any meeting with the FDA to BARDA and arrange for appropriate BARDA staff to attend the FDA meetings.
The Parties shall use Commercially Reasonable Efforts to achieve JDC approval of such updated Development Plan as soon as practicable after the End of Phase IIA FDA Meeting.
To facilitate CIRM’s participation in FDA Meetings, Loan Recipient shall notify CIRM as soon as practicable after it has scheduled an FDA Meeting, and shall, upon request, provide CIRM a copy of any data package or other information it intends to provide or has provided to the FDA, as well as any FDA Meeting minutes.
To facilitate CIRM’s participation in FDA Meetings, Grantee shall notify CIRM as soon as practicable after it has scheduled an FDA Meeting, and shall, upon request, provide CIRM a copy of any data package or other information it intends to provide or has provided to the FDA, as well as any FDA Meeting minutes.
FDA Meeting Notification Within 24 hours of scheduling meeting The contractor shall forward the dates and times of any meeting with the FDA relating to work funded under this contract to BARDA and to the extent practicable arrange for appropriate BARDA staff to attend the FDA meetings.
CIRM also has the right to review any data package(s) or other information, including confidential and/or proprietary information, provided by Grantee to the FDA in connection with such FDA Meetings, as well as any FDA Meeting minutes, and to share such information with CIRM’s confidential advisers.
Promptly after the End of Phase IIA FDA Meeting, the JPT shall meet to prepare, and shall submit to the JDC for approval, an updated Development Plan covering detailed Development Activities for the remainder of the 2018 calendar year.
The initial Development Plan shall be as set forth in Exhibit 2 hereto and shall (a) cover Phase II Development up to and including the End of Phase IIA FDA Meeting and any immediate follow-up Phase II Development activities directly resulting from such meeting and (b) a non-binding, high level projection of the Phase II Development activities to be undertaken thereafter.
Conditions Precedent to Obligations of the Company 41 8.1 Accuracy of Representations 41 8.2 Performance of Covenants 41 8.3 Governmental Consents 41 8.4 Agreements and Documents 41 8.5 Absence of Material Adverse Effect 42 8.6 FDA Meeting Minutes 42 8.7 No Restraints 42 8.8 No Legal Proceedings 42 9.
Rapporteurs Mtg - 2 docs Scientific Advice - 8 docs FDA: Meeting correspondence log from BLA m1.Also, discussion with FDA in Jan 09 to discuss advanced cancer pre- BLA submission.