Approvable Letter definition

Approvable Letter means a letter from the U.S. Food and Drug Administration (the “FDA”) informing the applicant that it has completed its review of the application and determined that there needs to be resolution of minor deficiencies, which are identified in such letter (21 CFR 814.44(e)), and/or completion of an FDA inspection that finds the manufacturing facilities, methods, and controls in compliance with the Quality System (QS) regulation, 21 CFR Part 820, and, if applicable, verifies records pertinent to the PMA as per 21 CFR 814.44(e)(1)(ii), and no other material requirements.

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Approvable Letter means a written communication to an applicant from FDA stating that FDA will approve the applicant's NDA if specific additional information or material is submitted or specific conditions are met in accordance with 21 CFR 314.110.

Approvable Letter means a letter from the FDA that an Application is basically approvable as described in 21 C.F.R. Part 314.110.

Examples of Approvable Letter in a sentence

• In such event (or in the event RELIANT fails to provide a written notice to PRONOVA under Section 3.3(a) or 3.3(b) within thirty (30) days after the date of RELIANT’s receipt of the Approvable Letter), the initial up front payment paid by RELIANT pursuant to Section 4.1 (as set out in Schedule 4.1) will remain with PRONOVA and this Agreement shall automatically terminate.

• CASH BONUS: Upon issuance by the FDA, of an "Approvable Letter" for DepoCyt, the Company will recommend to the Board of Directors that a portion of your 1997 Management Incentive Bonus is "moved ahead".

• Approvable Letter received June 2000, subject to certain conditions.

• Cash Bonus: Upon issuance by the FDA, of an "Approvable Letter" for DepoCyt, the Company will pay you a cash bonus of forty thousand dollars ($40,000), providing such issuance occurs during the Transition Period.

• If PharmaBio suspends one or more payments under this Section 2.1 and Columbia has not received an Approval Letter, but Columbia has received an Approvable Letter, then PharmaBio agrees to discuss in good faith with Columbia mutually acceptable arrangements under which PharmaBio could continue payments or a portion thereof under this Section 2.1, prior to receipt of an Approval Letter.

• Columbia agrees to promptly (and in any case not later than three Business Days after receipt) provide to PharmaBio copies of material correspondence to or from the FDA related to the Product including, without limitation, any Not Approvable Letter or other FDA action letters.

• Cephalon shall immediately notify ▇▇▇▇, the Commission, and any Interim Monitor, in writing, upon the occurrence of each of the following events: (i) submission of the NDA for OVF, (ii) receipt of a FDA Approvable Letter for OVF, (iii) Final FDA Approval of OVF, (iv) any determination by the FDA that ACTIQ may no longer be sold in the United States; and (v) any determination by the FDA that ACTIQ is not A/B Rated to ACTIQ SF.

• TCS agrees that applications for patent extension are to be made by Novartis in the sixty (60) day period following NDA approval; consequently, the Parties agree that preparation for such application shall begin upon FDA's issuance of an "Approvable Letter".

• In addition, within [*] days after the receipt of the Approvable Letter, Ergo shall furnish to Geneva its best estimate of the Launch Date.

More Definitions of Approvable Letter

Approvable Letter means the approvable letter dated December 21, 2004 from the FDA to Debiovision in respect of the Existing NDA.

Approvable Letter means a letter issued by the FDA as described in 21 C.F.R. Section 314.110, as amended from time to time.

Approvable Letter means a written communication from the FDA, in accordance with Section 21 CFR 314.110, which states that the NDA for the Product substantially meets all FDA requirements for approval to market, promote, and sell the Product in the Territory contingent upon the NDA applicant satisfactorily addressing any minor issues raised by the FDA. The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 406 of the Securities Act of 1933. HIND-ENDO SOLE AND EXCLUSIVE LICENSE AGREEMENT

Approvable Letter means a letter from the U.S. Food and Drug Administration (the “FDA”) informing the applicant that it has completed its review of the application and determined that there needs to be resolution of minor deficiencies, which are identified in such letter (21 CFR 814.44(e)), and/or completion of an FDA inspection that finds the manufacturing facilities, methods, and controls in compliance with the Quality System (QS) regulation, 21 CFR Part 820, and, if applicable, verifies records pertinent to the PMA as per 21 CFR 814.44(e)(1)(ii), and no other material requirements. The average Market Prices and share trading volumes provided for in this Section 1.2.1 shall be appropriately adjusted for any stock splits, stock dividends, and the like occurring after the date of issuance of this Warrant.

Approvable Letter means with respect to a Subject Product a decision by the EU Commission, a mutual recognition agreement in the European Union, or a letter from the FDA, which such decision, mutual recognition agreement or letter shall be, state or provide that the Subject Product is approvable.

Approvable Letter means a letter from the FDA pursuant to 21 CFR 314.110 with respect to the NDA for the Product with labeling substantially similar to the labeling requested by Columbia in the NDA as in effect on the date hereof. [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.