USA – FDA to require new safety warnings for opioids

The US Food and Drug Administration (FDA) last week announced new labeling updates and safety warnings for immediate-release (IR) and extended-released/long acting (ER/LA) opioids...

USA – FDA updates generic transdermal and topical delivery systems guidances

The US Food and Drug Administration (FDA) on Wednesday issued two revised draft guidances for generic drug submissions that use transdermal and topical delivery...

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