Prior Approval Supplement definition

Prior Approval Supplement means a change in the manufacture or testing of the Product that may be applicable to either a specific batch of Product or all Product that requires FDA approval prior to implementation of such change or sale of the Product.
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Prior Approval Supplement has the meaning given to it in section 506A of the Federal Food, Drug, and Cosmetic Act and §314.70(b) in the Code of Federal Regulations.
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Examples of Prior Approval Supplement in a sentence

  • Commencing not later than the [*****] anniversary of the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet Intrexon’s reasonably anticipated forecasts provided pursuant to Section 7.3. Halozyme shall review such supply strategy with Intrexon at least [*****], and prior to implementing any material change required by a CBE-30, a Prior Approval Supplement or equivalent regulatory filing.

  • Notice of acceptance shall state that the acceptance is absolute or subject to conditions specified in the notice, which may include FDA lot release in situations where a Prior Approval Supplement is required by the FDA.

  • Commencing not later than the *** anniversary of the Effective Date, Halozyme shall be responsible for implementing a commercially reasonable supply strategy for API to meet ViroPharma’s reasonably anticipated forecasts provided pursuant to Section 7.3. Halozyme shall review such supply strategy with ViroPharma at least ***, and prior to implementing any material change required by a CBE-30, a Prior Approval Supplement or equivalent regulatory filing.

  • The Borrower shall have obtained FDA approval of the BIVIGAM Prior Approval Supplement, and the Administrative Agent shall have received evidence satisfactory to it of such approval.

  • All Changes that impact the specifications, yield, quality, etc of the API must be submitted to Reliant QA for review and approval prior to implementation as such changes may require a Prior Approval Supplement to the affected NDA.

  • The Borrower shall have obtained FDA approval of either (x) the BIVIGAM Prior Approval Supplement or (y) the RI-002 Biologics License Application, and the Administrative Agent shall have received evidence satisfactory to it of such approval.

  • X [PSK recommends discontinuing article - Orexo to take over per Orexo 10/22/12] TIRF review article $17,750 [Due upon submission, awaiting final author approval to submit manuscript] X [PSK recommends immediate termination] Dissolution Manuscript Completed IND and NDA transfer - To be completed by December 24th 2012 Prior Approval Supplement for Change in Manufacturer Submit Quarterly PSUR Submit REMS Assessment Report Submit REMS Bridging Report Submit Quarterly PSUR Approx.

  • Where the Fujifilm regulatory assessment deems that a Prior Approval Supplement to the Dyax Biologics License Application may be required as a result of a planned new product introduction, Fujifilm will notify Dyax in writing at the earliest opportunity in order to allow consideration of the regulatory strategy and timelines.

  • Dyax will use Commercially Reasonable Efforts to submit a Prior Approval Supplement to the FDA within ten (10) Business Days of receiving notification of such a new product.