In aggregate, these individuals sign over 4,000 NDAs
4) As a practical matter, many taxpayers will be unwilling to incorporate the required regulatory language in their NDAs
and risk disclosure of the confidential non-tax information.
Pharmaceutical companies submit thousands of NDAs
annually to the FDA, with the hopes of introducing new drugs, changing recommended dosages, or marketing medications for different therapies.
The filing of an NDA
with the FDA is an important step in the approval process in the United States.
The Junovan NDA
submission includes efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received Junovan, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received Junovan in the controlled Phase III trial conducted by the Pediatric Oncology Group (POG) and the Children's Oncology Group (COG), sponsored by the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI).
Schaber has most recently served as an NDA
and FDA regulatory strategic advisor to DOR.
Under the terms of the agreement between Ligand and Wyeth, Ligand is entitled to receive additional milestones upon submission of an NDA
equivalent in a major market country ex-U.
Among other things, there can be no assurances that any of Hana's development efforts relating to its product candidates will be successful or that the FDA will approve Hana's planned NDA
submission relating to Zensana or its other product candidates.
Chief Executive Officer and President for Covalent Group, commented, "The first NDA
contract included in today's announcement is in support of a drug whose use will be based on a pharmacogenomically tailored approach to the treatment of patients with chronic heart failure.
The company submitted an NDA
for ZEGERID Capsules 40 mg and 20 mg to the FDA in April 2005 and submitted an NDA
for ZEGERID Chewable Tablets 40 mg and 20 mg to the FDA in May 2005.
Ximeta's breakthrough NDAS
technology enables instant, fast, and secure LAN connections without the need for IP configuration or a network server.
Ferring has been using Target Health's current EDC software, Target e*CRF, for more than five years for programs resulting in two NDA