Not Approvable Letter definition

Not Approvable Letter means a letter from the FDA that an Application may not be approved, as described in 21 C.F.R. Part 314.120.
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Not Approvable Letter means a letter or other official communication from FDA providing notice that an application filed with FDA may not be approved, as defined in FDA regulations set forth in 21 C.F.R. 314.120.
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Not Approvable Letter means a letter from the FDA pursuant to 21 CFR 314.120 with respect to the NDA for the Product.
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Examples of Not Approvable Letter in a sentence

  • We held an end-of-review meeting with the FDA related to the FDA Not Approvable Letter in October 2006.

  • On May 28, 2004 POZEN received a Not Approvable Letter (NAL) from the Division.

  • In cases where a planning obligation is only dealing with financial contributions the LPA will encourage developers to make a unilateral undertaking and to make the relevant contributions on the granting of planning permission and/or at different stages of development.

  • Reference is made to a Not Approvable Letter for Patanase dated October 27, 2005, and a resubmission from the sponsor dated September 26, 2007.

  • Not Approvable Letter, Steven Galson, M.D., Acting Director of the Center for Drug Evaluation and Research, FDA, to Barr Research, Inc.

  • On July 9, 2007, a Not Approvable Letter was issued and stated that the supplied clinical data indicated that the proposed Ferinject dose regimen was accompanied with an unacceptable risk for death, serious adverse reactions and clinically important hypophosphatemia.

  • The following review covers the regulatory history of sugammadex by summarizing the prior reviews completed by DPARP, as well as data from a new repeat-dose clinical study presented by the Applicant to address the deficiencies with respect to the evaluation of anaphylaxis, as cited in the Not- Approvable Letter, dated July 31, 2008.

  • Asacol®, an agent for treating inflammatory bowel disease that we will be marketing jointly with Zeria Pharmaceutical Co., Ltd., has completed phase III clinical trials and a New Drug Application (NDA) has been filed.Overseas, the antiparkinson agent (adjunct therapy) KW-6002, which had been filed for approval with the U.S. Food and Drug Administration (FDA), received a Not Approvable Letter in February 2008.

  • Stiefel, a GlaxoSmithKline Company, has submitted a complete response to the Not- Approvable Letter issued on June 10, 2005 for a topical combination product Veltin Gel, containing clindamycin phosphate 1.2% and tretinoin 0.025%.


More Definitions of Not Approvable Letter

Not Approvable Letter means a letter from the FDA pursuant to 21 CFR 314.120 with respect to the NDA for the Product that has been filed with the FDA prior to the date hereof, for the indication prevention of respiratory distress syndrome in premature infants (RDS).
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Related to Not Approvable Letter

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Certificate of approval means a certificate of approval obtained from the

  • Approval of a vehicle means the approval of a vehicle type with regard to sound;

  • Consent Agreement shall have the meaning set forth in Section 14.2.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Approval means the prior written consent of the Authority and "Approve" and "Approved" shall be construed accordingly;

  • Contract Modification means any changes in the terms or provisions of the Contract which are reduced to writing and fully executed by both parties.

  • leasing agreement means an agreement by which one person (the lessor) grants a right to possession or control of an object (with or without an option to purchase) to another person (the lessee) in return for a rental or other payment;

  • Support Agreements has the meaning set forth in the Recitals.

  • PILOT Agreement means the Agreement for Payments in Lieu of Ad Valorem Taxes entered into by and among the Board, the Company, the City and the County.

  • Support Agreement has the meaning set forth in the Recitals.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Disclosure Statement Approval Order means the Final Order approving, among other things, the adequacy of the Disclosure Statement pursuant to section 1125 of the Bankruptcy Code.

  • the Approved Guidance means such guidance on the obtaining, recording and maintaining of information about costs and on the breaking down and allocation of costs by reference to Approved Reporting Currencies as may be published by Monitor; “Approved ReportingCurrencies” means such categories of cost and other relevant information as may be published by Monitor; “other relevant information” means such information, which may include quality and outcomes data, as may be required by Monitor for the purpose of its functions under Chapter 4 (Pricing) in Part 3 of the 2012 Act.

  • Conditions of Approval means condition(s) imposed by the Municipality in the approval of a land development application, including any conditions contained in the annexure(s) and/or plans and/or attachment(s) that form part of the approval and/or are referred to in the approval of the land development application;

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Consent and Agreement means the Manufacturer Consent and Agreement [ ], dated as of even date with the Participation Agreement, of Airframe Manufacturer.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Program Support Agreement means and includes any Liquidity Agreement and any other agreement entered into by any Program Support Provider providing for: (a) the issuance of one or more letters of credit for the account of any Conduit Purchaser, (b) the issuance of one or more surety bonds for which the such Conduit Purchaser is obligated to reimburse the applicable Program Support Provider for any drawings thereunder, (c) the sale by such Conduit Purchaser to any Program Support Provider of the Purchased Interest (or portions thereof) maintained by such Conduit Purchaser and/or (d) the making of loans and/or other extensions of credit to any Conduit Purchaser in connection with such Conduit Purchaser’s securitization program contemplated in this Agreement, together with any letter of credit, surety bond or other instrument issued thereunder.

  • Sponsor Letter Agreement has the meaning set forth in the recitals to this Agreement.

  • Sponsor Support Agreement has the meaning set forth in the recitals to this Agreement.

  • Consent Agenda means a portion of a meeting that lists items of business which are routine in nature and do not require substantial discussion and/or debate.

  • Sponsor Management Agreement means the Management Agreement between certain of the management companies associated with the Sponsors and the Borrower.

  • Licensing Agreement means a commercial agreement between a design approval holder and a production approval holder (or applicant) formalizing the rights and duties of both parties to use the design data for the purpose of manufacturing the product or article.

  • Waiver Agreement means an agreement between

  • IP Assignment Agreement has the meaning set forth in Section 3.2(a)(iii).