Submission Batch definition

Submission Batch means a Batch that is manufactured in order to generate data, results and/or other information to be submitted or intended to be submitted to the FDA for the purpose of seeking the Regulatory Approval for the Product in the Territory.
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Examples of Submission Batch in a sentence

  • IntelGenx's obligation under this Section 2.7 shall continue until the Manufacturer successfully manufactures a Submission Batch for such Product.

  • IntelGenx’s obligation under this Section 2.7 shall continue until the Manufacturer successfully manufactures a Submission Batch.

Related to Submission Batch

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Submission Location means the submission location identified as such in the Summary of Key Information.

  • Expedited Deliverability Study means a deliverability study that an eligible Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S) that may determine the extent to which an existing or proposed facility satisfies the NYISO Deliverability Interconnection Standard at its requested CRIS level without the need for System Deliverability Upgrades. The schedule and scope of the study is defined in Sections 25.5.9.2.1 and 25.7.1.2 of this Attachment S.