The FDA released several draft guidances today that it said it hopes will assist generic drug makers get their products through the development and approval process while keeping the agency’s Risk Evaluation and Mitigation Strategy, or REMS, safety controls in place.
“Bringing together multiple products under one REMS program can have real benefits for the health care system, including for providers. But, the generic drug maker has to negotiate with the brand firm to enter into a shared REMS programs before the generic drug can be approved. We know that (Read more...)
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