Regulatory Learnings from the Real World

In March, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM). voted 18-8 that Opana ER’s benefits do not outweigh its risks. And on June 8th, the other shoe dropped.
Source: drugwonks.com Blog - Category: Pharmaceuticals Source Type: blogs