Seidel called the supplemental application "phase one" of a broader effort to address the growing interest from U.S. policymakers in making sure that any data obtained with federal funds be accessible to the general public.
"Once F.D.A. receives that supplemental application, the F.D.A. intends to approve it promptly".
The supplemental application is for use in treating non-acetaminophen based liver failure, for which the only current treatment is transplant.
Information as to the requirements for the supplemental application may be retrieved from the project director who supervises your potential collaborator's grant.
(RTF 10 kb) Additional file 2: Appendix A: Supplemental Tables.
None of these patients needed anything other than supplemental application of nasal oxygen.
We then examined the FDA's letters accompanying the remaining supplemental application approvals to exclude those unrelated to supplemental indications, such as inclusion in the drug label of additional clinical data supporting an already approved indication (fig 1).
Trees were watered daily, with weekly application of nutrient solution (MiracleGro) and with supplemental application of Osmocote (Scott's Miracle-Gro Products; 19-6-12 N-P-K) every two months at the indicated rate of 10 g/pot.
We used both the Drugs@FDA database and the FDA's Orphan Drug Product database to determine whether the FDA granted orphan drug designation for each supplemental application as well as for each study drug at the time of original approval.
Complete supplemental application as determined by the pharmacy program.
