Efficacy Supplement definition

Efficacy Supplement means an NDA submission to FDA requesting approval for a change to an approved product, including a request for approval of a new indication for an approved product.
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Efficacy Supplement means a supplement to a Regulatory Approval, including a BLA, proposing to make one or more related changes to a product’s labeling, including adding or modifying an indication, pursuant to 21 CFR § 314.3, filed with the FDA, or an equivalent supplement filed with any Regulatory Authority proposing such equivalent changes to a product’s labeling.
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Related to Efficacy Supplement

  • Dietary supplement means a product, other than tobacco, that:

  • Country Supplement means a supplement to this Prospectus specifying certain information pertaining to the offer of Shares of the Company or a Fund or Class in a particular jurisdiction or jurisdictions.

  • mobility supplement means a supplement to which paragraph 9 of Schedule 4 refers;

  • Enhancement Agreement means any agreement, instrument or document governing the terms of any Series Enhancement or pursuant to which any Series Enhancement is issued or outstanding.

  • Pharmacovigilance Agreement has the meaning set forth in Section 5.1.