ARTICLE | Regulation
System reset in 2008
January 21, 2008 8:00 AM UTC
Years of negative publicity over adverse effects of drugs and unrelenting political pressure to minimize risks have reshaped the American regulatory environment, effectively creating new requirements for approval that sponsors and investors ignore at their peril.
Legal criteria for approvals haven't changed, but the FDA Amendments Act of 2007 (FDAAA) and energetic congressional oversight over the last four years have reset the regulatory mechanism...