Common use of FDA Submissions Clause in Contracts

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. The Contractor shall provide the CO and COR all documents submitted to the FDA. Contractor shall provide the COR Government 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 for CO/COR for review, the COR Government will provide feedback to ContractorContractor within [**] business days of receipt. • If BARDA reviews the CO and the COR review draft documents, the Contractor shall revise their documents to address ▇▇▇▇▇the Government’s written concerns and/or recommendations prior to FDA submission. • Final FDA submissions shall be submitted to the CO and the COR concurrently or no later than [***] of their submission to FDA.