FDA Withdraws 23 Outdated Draft Guidances on Drug Products
The Food and Drug Administration is withdrawing 23 out-of-date draft guidances, as part of a clean-up of its draft guidance documents issued before 2010. The draft guidances being withdrawn cover topics like drug development and approval, current good manufacturing practice…
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(CGMP) requirements for drugs and labeling in abbreviated new drug applications (ANDAs). According to FDA’s Center for Drug Evaluation and Research, FDA has in most cases developed other guidances to replace the withdrawn documents.