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.
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US FDA extends review timeline for the multiple sclerosis BLA until March 28, 2017 to have time to review new information about commercial manufacturing process, Roche says.
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Human factors could be the key to data integrity. Agency and industry officials envision ways to stem the flow of data integrity warning letters and ensure data integrity by design with robust electronic production control systems and strong top-down cultural reforms.