Last Minute Drug Approvals Linked to Postmarket Safety Issues

摘要

Drugs approved by the FDA just before mandated deadlines are more likely to have safety issues after entering the market than those approved at other times, according to a study in the March 27 New England Journal of Medicine.1 Coincidentally, on that date, the FDA announced the first group of marketed medications, including the atypical antipsychotic clozapine (Clozaril), for which it is requiring additional safety plans under the FDA Amendments Act of 2007.