REMS sans registry may get one

In backing the approval of InterMune's pirfenidone for idiopathic pulmonary fibrosis, an FDA panel voted that the drug's safety had been adequately assessed, despite some concerns. Panelists urged InterMune to track long-term safety data via a patient registry, an item missing from the company's proposed risk evaluation and mitigation strategy. InterMune says it's open to whatever the FDA deems necessary in its final decision-making. Article

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