Common use of FDA Submissions Clause in Contracts

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. 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 COR for review, the COR/ACOR COR 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 COR concurrently or no later than 5 calendar days of their submission to FDA.