NRx Pharmaceuticals reaches alignment with FDA on manufacturing plan

NRx Pharmaceuticals announced that it had a meeting and a written response from the Food and Drug Administration last week regarding its lead compound, NRX-101. In response to a request for Type C guidance on the chemistry, manufacturing and controls aspects of the NRX-101 program, FDA provided Written Responses on January 10th. As previously announced in October 2022, an updated NRX-101 module 3 was submitted to add the intended commercial manufacturer to the IND. With FDA’s written response, it appears that NRx Pharmaceuticals has reached alignment with the FDA regarding its proposed registration manufacturing plan. A Type B meeting with the FDA was held on January 11, 2023. Minutes of the meeting are expected to be available in approximately 30 days.