HHS OIG Reviewing REMS, SBIR Eligibility, Patient Safety Organizations
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A number of topical issues will be investigated by the HHS Office of Inspector General, according to its work plan for fiscal year 2013. Pharma industry issues are concentrated in the Medicare and Medicaid space.
FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision – but use of Risk Evaluation and Mitigation Strategies is actually declining. As FDAAA turns three, it is clear that REMS are going through some growing pains. The new tools will be refined, but they are definitely here to stay.