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Home » FDA Criticized for Dropping Human Trial Requisite for Restasis Generics
FDA Criticized for Dropping Human Trial Requisite for Restasis Generics
September 24, 2013
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dry eye treatment Restasis, according to a slew of comments and letters posted online in response to an agency draft guidance on the subject.