NDA Package definition
NDA Package means a complete package of data and information which the FDA needs in a NDA for the Product.
NDA Package means the preclinical studies, Clinical Studies, manufacturing and controls, regulatory, quality and any other Data necessary to proceed with an NDA filing. An updated list of Patent Rights Controlled by Servier or Pfizer, as applicable, that is associated with such NDA Package shall be included therein.
NDA Package means Anesta"s NDA for OT-fentanyl Products and all accompanying data and information including supplements and amendments submitted by Anesta to the FDA in connection with such NDA.
Examples of NDA Package in a sentence
Acucela agrees that Otsuka shall have the sole discretion to accept or reject the Clinical Trial Protocol and NDA Package developed by the Implementation Team and any FDA requirement thereof.
Following any Go Decision, Neurocrine will have responsibility for preparing the complete and final NDA filing for the IR Product and/or MR Product as set forth in this Section 4.3(c) (the "NDA Package").