FDA Meeting definition
Examples of FDA Meeting in a sentence
Promptly following the Initial FDA Meeting, Vernalis shall transfer the MAM Product IND to Endo free from any Encumbrance.
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.
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.
FDA Meeting of the Tobacco Products Scientific Advisory Committee.
Briefing information for the FDA Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.
The Option will be exercisable by EIP at any time during the period commencing on the Effective Date and ending upon the earlier to occur of (i) six (6) months after the FDA Meeting, or (ii) twenty-four (24) months after the Effective Date (the “Option Period”).
Senetek may appoint a representative to attend the FDA Meeting at the cost and expense of Senetek.
The FDA described its initiative as tentative and invited the public to submit comments to help the agency clarify the contours of the new diagnostic domain (FDA Meeting, pp.
At least thirty (30) days prior to the FDA Meeting, but in no event less than ten (10) days prior to submission of the briefing materials, the Company shall provide Parent with draft briefing materials that the Company intends to submit to the FDA for the FDA Meeting and shall provide Parent with the opportunity to comment on such briefing materials, which comments will be considered and addressed in good faith.