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Replies to post #218276 on Biotech Values
12/07/20 9:41 AM
In the CRL, the FDA cited their need to conduct pre-approval inspections at two of the company’s third-party manufacturing facilities that could not be conducted due to travel restrictions. In addition, the FDA raised questions related to testing, labeling, and features of the combination product unrelated to the drug constituent.
In addition, the FDA indicated that there were deficiencies at the third-party facility where the Company’s off-the-shelf alcohol swabs are manufactured. scPharmaceuticals will request a Type A meeting with the FDA to discuss the issues described in the CRL and steps required for the resubmission of the NDA for FUROSCIX.
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