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ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit

 
• By Derrick Gingery

Generics must be able to be administered without provider intervention or patient retraining, draft guidance says.

FDA may have set a high bar for generic combination products in new draft guidance stating that the devices must not require provider intervention or patient retraining. Not only could the policy make it difficult for competing substitutable products to reach the market, but by raising the development cost, the studies could also limit some of the savings those generics could generate.

The agency's new draft guidance: "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA," released Jan

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