FDA
released guidance providing recommendations to holders of new drug applications
(NDAs) and abbreviated new drug applications (ANDAs) regarding the types of
changes to be documented in annual reports. The guidance describes chemistry,
manufacturing, and controls (CMC) postapproval manufacturing changes that FDA
has determined will likely have a minimal potential to have an adverse effect
on product quality. FDA, therefore, states that applicants should document
these changes in an annual report.
A
list of examples of CMC postapproval manufacturing changes previously submitted
under manufacturing supplements is provided that FDA has determined to be of
low risk to product quality. The guidance also provides examples of minor
changes to be documented in an annual report that were previously published in
FDA’s Scale-up and Postapproval Changes (SUPAC) guidance documents and other
postapproval change CMC guidance documents.
Posted by Tim Sandle
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