The EU Directive requires retention for at least 5 years after trial end (for nonregulatory submission trials) and for a trial leading to a product licensing submission, at least 2 years after the last approval of a marketing application in the EU.
For example, an analysis of 198 new drug application and biological license application submissions, reviewed by the US Food and Drug Administration's Division of Pharmacometrics during the period 2000 2008, suggested an impact of the pharmacometrics analysis on drug approval and labeling decisions in ~65% of the cases.
Neumedicines is advancing the development of rhuIL-12 towards a Biologic License Application submission to the FDA under the Animal Efficacy Rule for the treatment of the hematopoietic sub-syndrome of ARS [ 54].
Last September, the agency ruled that U.S. journals needed a government license to edit submissions from these four countries (Science, 19 September 2003, p. 1646).
6. License to Use Submissions: Sponsor shall have the right to disqualify any entries that they deem to be obscene, vulgar, sexually explicit, lewd, derogatory, inappropriate, or otherwise not in good taste, as determined by the Sponsor in its sole discretion.
The use of PROs as clinical trial endpoints continues to be widespread, with over 45% of all New Molecular Entity (NME) or Biologics License Applications (BLA) submissions between 2006 and 2010 utilizing these instruments in some capacity [ 2, 3].
She has had oversight of the HE/OR contributions to licensing and HTA submissions for the past decade and previously specialized in outcomes assessment and clinical studies.
With our revised SPA, the FDA has agreed that the pivotal ADAPT study could support a future Biologics License Application (BLA) submission if the study objectives are met".
The world's largest Internet retailer plans to license content, then accept submissions online that may then be sold through its Kindle ebook store.
You also hereby grant each user of the YouTube Website a non-exclusive license to access your User Submissions through the Website, and to use, reproduce, distribute, prepare derivative works of, display and perform such User Submissions as permitted through the functionality of the Website and under these Terms of Service.
