FDA forced to reset how it regulates some ophthalmic drugs following court loss
When the FDA lost a crucial court decision last year, the fallout seemed inevitable. Now, the decision is forcing the agency’s hand and requiring it to regulate medical products in a gray area as medical devices, if they meet both definitions of medical devices and drugs.
That court decision hit FDA’s policy agenda once again Tuesday, as the agency said in immediately effective guidance that it will now depart from how it generally regulates ophthalmic dispensers packaged together with an ophthalmic drug. Previously regulated as drugs, they now must be considered combo products.
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