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.

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

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.

Examples of Approvable Letter in a sentence

• The evaluation of indiplon for sleep maintenance includes both indiplon capsules and tablets.The 2006 FDA Approvable Letter requested that we reanalyze data from certain preclinical and clinical studies to support approval of indiplon 5mg and 10mg capsules for sleep initiation and middle of the night dosing.

• The applicant has not adequately addressed the clinical issues identified in the 20-OCT-2003 Approvable Letter.

• The 2006 FDA Approvable Letter also requested reexamination of the safety analyses.

• The Approvable Letter is an official notification that the FDA is prepared to approve the Surfaxin New Drug Application and contains conditions that the applicant must meet prior to obtaining final U.S. marketing approval.

• The FDA Not Approvable Letter requested that we reanalyze certain safety and efficacy data and questioned the sufficiency of the objective sleep maintenance clinical data with the 15 mg tablet in view of the fact that the majority of our indiplon tablet studies were conducted with doses higher than 15 mg.

More Definitions of Approvable Letter

Approvable Letter means a written communication, as defined in 21 ----------------- CFR 314.3(b), from FDA to Ergo, stating that FDA will approve the applicable NDA if specific additional materials are submitted or specific conditions are met.

Approvable Letter means a written communication from the FDA to the owner of the application for Regulatory Approval stating that the FDA will not approve the application, or that the FDA will approve the application if additional information is submitted or specific conditions are met, pursuant to 21 C.F.R. Section 314.3(b).

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 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.

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

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 issued by the FDA indicating the pending approval of an NDA relating to a product, as defined in 21 CFR Section 314.110.