GMP Guideline for Inspection - PAHO/WHO

The Celgene application for Thalidomide was considered by FDA's Dermatologic and Ophthalmic Drugs Advisory Committee on Sept. 4-5, 1997 and on Sept 9-10, 1997, an open public scientific workshop was held to discuss the potential benefits and risks of thalidomide being reintroduced into the marketplace (6). ................
................