FDA Criticized for Dropping Human Trial Requisite for Restasis Generics

The FDA should explain why it has decided to nix the need for human studies to demonstrate bioequivalence to Allergan’s dry eye treatment Restasis, according to a slew of comments and letters posted online in response to an agency draft guidance on the subject. The letters come from a variety of commenters, not just from the drug’s maker, which issued a 43-page response in support of its product.
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