FDA Issues Guidance On Proving Generic-Drug Stability

Law360, New York (September 25, 2012, 8:33 PM EDT) -- The Food and Drug Administration on Tuesday answered a long-standing question from generic-drug sponsors, saying that generics makers should follow the same standards as new drug applicants when proving the stability of their drugs.

In a draft guidance document released Tuesday, the FDA said abbreviated new drug applications should follow the same guidelines, issued by the International Conference on Harmonisation, that new drug sponsors use.

“Although the ICH stability guidances were developed for new drug applications to ensure the stability of new drug substances and products,...
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