FDA's rejection of two applications for new eye drugs in the past week resulted from failures to demonstrate manufacturing readiness. Such failures are the most common reason for manufacturing-driven complete response letters (CRLs), agency investigators say.
Manufacturing Problems Aren't Rising, But It Was A Hot July
Lack of readiness derails eye drugs from Valeant and Ocular, which now must convince FDA they know what they are making; meanwhile, an expert shares how mistake-proofing processes can help.