FDA Audit definition

FDA Audit has the meaning ascribed to it in Section 5.10.
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Examples of FDA Audit in a sentence

  • Purchaser shall provide Sellers with a copy of any FDA comments or observations relating to the FDA Audit and shall provide Sellers with a copy of any draft response to the FDA at least three days prior to submission.

  • Purchaser shall consult with Sellers and accept reasonable suggestions of Sellers regarding the planning, coordination and implementation of any such Modifications, as well as any communications with the FDA relating to the FDA Audit or the Modifications.

  • Subsequent to the Closing, Purchaser shall inform Sellers of any and all contacts and communications from the FDA related to the FDA Audit described in Section 5.10 herein, in sufficient time for Sellers to participate in person in any inspections, investigations or meetings by or with the FDA related to the FDA Audit.

  • To the extent it may do so, Purchaser will not schedule any audits, inspections, investigations or meetings with the FDA relating to the FDA Audit without ensuring that a representative of Sellers can participate in person, if they so choose.

  • Following completion of the Mock FDA Audit, unless otherwise agreed by the Parties, BioVectra will address the findings from the Mock FDA Audit prior to Keryx’s submission of the NDA Manufacturing Supplement (the “Key Findings”), and [**] in addressing the Key Findings as appropriate.

  • Licensed establishments will be selected for field evaluation based on random selection methodologies detailed in the FDA Audit Manual (Draft), June 30th, 2004.

Related to FDA Audit

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Initial Audit is Bank’s inspection of Borrower’s Accounts, the Collateral, and Borrower’s Books, with results satisfactory to Bank in its sole and absolute discretion.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]