FDA-Ordered Safety Studies for Approved Drugs and Devices Remain Incomplete Years After Market Launch
Source Summary
The FDA permits pharmaceutical and medical device companies to conduct safety and efficacy studies after product approval to accelerate market entry. Records show that many of these required postmarket studies are significantly behind schedule or overdue.
Why it matters
Incomplete postmarket studies mean the FDA and public lack full safety and efficacy data for drugs and devices already in widespread use.
