Common use of FDA Submissions Clause in Contracts

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 the opportunity to review and comment upon all draft submissions before submission 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.” • The If draft documents are submitted to the COR for review, the COR will provide feedback to Contractor within 10 business days of receipt. • If corrective action is recommendedBARDA reviews draft documents, the Contractor must take into consideration shall revise their documents to address ▇▇▇▇▇’s written concerns raised by COR/CO. The COR/CO may request a response in writing for a specific concern and/or recommendations prior to FDA submission. • Final FDA submissions shall be submitted to the CO and COR concurrently or no later than 1 5 calendar day days of their submission to FDA.