The Complicated World of REMS

Unwinding Risk Mitigation

Sep 28, 2010 No Comments

IN 2007, with the passage of the Food and Drug Administration (FDA) Amendments Act, the FDA was granted new authority to require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug outweigh its risks. An REMS, which can be required at the time a drug is approved and/or once it has gone to [...]

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Health Care Reform: What’s Next For Pharmacists?

Sep 28, 2010 No Comments

AS WE GO TO PRESS with the fall 2010 edition of InterSections, nearly 100 ASHP members have just finished an intensive day lobbying congressional representatives and their staff members on issues critical to our profession. It has been a busy, but important, time for ASHP members and the patients they serve. With the passage of the Patient Protection and Affordable Care Act, [...]

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