Greater Clarity Needed On CGT Pathway In US

Several aspects of the FDA’s draft guidance on the pathway for competitive generic therapies require clarification, according to detailed feedback submitted by industry.

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The FDA Must Clarify Certain Aspects Of The CGT Pathway, Industry Says • Source: Shutterstock

Greater clarity is needed on multiple aspects of the US Food and Drug Administration’s latest draft guidance on competitive generic therapies, according to comments submitted by several generics firms and industry representatives.

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