FDA announced a new set of product-specific guidances to support industry in identifying appropriate science-based methodologies
and evidence for developing generic drugs. The batch contains 63 product-specific guidances, including 22 new guidances and
41 revised guidances. Of these, four are new draft guidances and 31 are revised guidances for complex drug products, including
23 products that, to date, do not have generic competition. The FDA has issued more that 1,600 product-specific guidances since
2007.
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