FDA Submissions Sample Clauses
The FDA Submissions clause outlines the responsibilities and procedures for submitting required documents and information to the U.S. Food and Drug Administration (FDA) in connection with a product or project. Typically, this clause specifies which party is responsible for preparing, filing, and maintaining regulatory submissions, such as Investigational New Drug (IND) applications or New Drug Applications (NDA), and may address the sharing of data or regulatory correspondence. Its core function is to ensure regulatory compliance and clarify which party manages interactions with the FDA, thereby reducing confusion and potential delays in the approval process.
FDA Submissions i. The Contractor shall provide BARDA the opportunity to review and comment upon all documents submitted to the FDA. In addition, an electronic copy of the final FDA submissions will also need to be submitted. All documents shall be duly marked as either “Draft” or “Final.”
1. If draft documents are submitted to the COR/ACOR for review, the COR/ACOR will provide feedback to Contractor within 10 business days of receipt, or sooner as necessary to address FDA deadlines or requests.
2. If BARDA reviews draft documents, the Contractor shall revise as appropriate their documents to address ▇▇▇▇▇’s written concerns and/or recommendations prior to FDA submission.
3. Final FDA submissions shall be submitted to the CO and COR/ACOR concurrently or no later than 5 calendar days of their submission to FDA.
FDA Submissions. The Contractor shall provide the COR the opportunity to review and comment upon all draft submissions before submission to the FDA. Contractor shall provide COR with an electronic copy of the final FDA submission. All documents shall be duly marked as either “Draft” or “Final.” • The COR will provide feedback to Contractor within 10 business days of receipt. • If corrective action is recommended, the Contractor must take into consideration concerns raised by COR/CO. The COR/CO may request a response in writing for a specific concern prior to FDA submission. • Final FDA submissions shall be submitted to the COR concurrently or no later than 1 calendar day of their submission to FDA.
FDA Submissions. The Contractor shall provide the COR all documents submitted to the FDA. Contractor shall provide the COR with an electronic copy of the final FDA submission. All documents shall be duly marked as either “Draft” or “Final.” • If draft documents are submitted to the COR for review, the COR will provide feedback to Contractor. • If BARDA reviews draft documents, the Contractor shall revise their documents to address ▇▇▇▇▇’s written concerns and/or recommendations prior to FDA submission. • Final FDA submissions shall be submitted to the CO and COR concurrently or no later than [***] of their submission to FDA.
FDA Submissions. EchoCath shall promptly upon execution of this Agreement, transfer to EP MedSystems all rights with respect to and pursuant to any and all FDA 510(k) approvals relating to the Products. EchoCath will provide reasonable assistance and cooperation for such FDA applications, and EP MedSystems will reimburse EchoCath for its reasonable and customary costs and expenses and for its out-of-pocket expenses for such assistance, subject to EP MedSystems' authorization for these costs.
FDA Submissions. The Contractor shall provide BARDA all documents submitted to the FDA. Contractor shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either “Draft” or “Final.” When draft documents are submitted for BARDA review, BARDA will provide feedback to Contractor within [***] of receipt. When BARDA reviews draft documents, the Contractor shall revise their documents to address ▇▇▇▇▇’s written concerns and/or recommendations prior to FDA submission. Final FDA submissions shall be submitted to BARDA concurrently or no later than [***] of their submission to FDA.