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

  • 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.

  • 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.

  • 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.

  • As a part of the resubmission, the Applicant has provided the results of a repeat-dose clinical study (P101), as outlined in the Not Approvable Letter.

  • 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%.

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

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


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 means this Consent Agreement, duly signed and concluded between the Commission and the Respondent, as contemplated in section 40(1) of the Act.

  • 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 written consent of the Authority.

  • 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:

  • 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 of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • 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).

  • Required Consent has the meaning set forth in Section 4.4.