"Monitoring for thalidomide induced birth defects", American Journal of Medical Genetics

Draft of Smithells' proposed comment on the (forthcoming) publication, By J. D. Erickson et al., "The return of thalidomide: are birth defects surveillance systems ready?", American Journal of Medical Genetics, vol. 73, no. 3 (December 1997). Includes correspondence with Erickson.

Also includes correspondence and initial returns on a global thalidomide survey conducted in the summer of 1997, as well as contemporary reports in the media on the comeback of thalidomide, which received FDA approval in 1998.

There also is correspondence with Bruce A. Williams, Vice President of the Celgene Corporation, 1999. Celgene negotiated an education and restricted distribution system (S.T.E.P.S) with the FDA on approval of their thalidomide product. S.T.E.P.S. stands for 'System for Thalidomide Education and Prescribing Safety'. A S.T.E.P.S. folder is included here.

1997-1999

2 files