What is the FDA going to do if there is a fetal exposure to Thalomid (thalidomide)?
The FDA has set up additional safeguards for the use of Thalomid (thalidomide) by men and women. The Agency has worked closely with the manufacturer, the Canadian Thalidomide Victims Association, and others to develop a program to ensure the safe and effective use of Thalomid (thalidomide). If there is even ONE fetal exposure to Thalomid (thalidomide), the Agency will re-evaluate the entire distribution system and take the necessary steps to ensure that all deficiencies are corrected.
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