What is FDAs post-marketing strategy?
Any suspected fetal exposure to Thalomid (thalidomide) or any serious adverse drug event must be reported to the FDA via the Medwatch report form and also to the Celgene Corporation. The Agency will continue to evaluate the S.T.E.P.S. program, which will include inspections of pharmacies, and reviewing the data from and the procedures associated with the national physician/patient registry.
