FDA announced that the Center for Drug Evaluation and Research (CDER) has reviewed the status of draft guidance documents issued before 2010 to determine what should be done with those guidance documents going forward. According to the Federal Register, CDER will withdraw guidance documents that are not up to date and lack current information. CDER will determine which guidance documents reflect the agency’s current thinking and either revise or finalize the documents.
In the review, CDER identified 23 draft guidance documents for withdrawal in the areas of CGMP compliance, development of antimicrobial drugs, abbreviated new drug applications (ANDAs), labeling of ANDAs, and more. Guidance documents to be withdrawn include but are not limited to:
CDER has identified guidance documents in the following topics and are developing a plan for revision or finalization:
More information on the withdrawal, revision, and finalization of these guidance documents can be found on CDER’s website.
Source: Federal Register