Whose Burden Is It Anyway? REMS’ Health Care Impact Belongs To FDA, PhRMA Says
Industry group contends that FDA should assess whether a REMS places an undue burden on the health care industry – because asking companies to do that evaluation would be an additional burden on the health care system.
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Industry must weigh value of strengthening agency’s armamentarium as FDA continues to seek outside collaborations in follow-up to 2011 publication.
Risk Communication Advisory Committee suggests that adding the agency imprimatur to REMS materials may help distinguish it from promotional mail and ensure providers read the communications.
FDA’s Risk Communications Advisory Committee will address methods for presenting REMS information and assessing whether it is reaching the target population.