Monday, December 16, 1996
Representatives of the biotechnology and pharmaceutical industries
and the FDA have been working hard to meet the agency's deadline on Friday this
week on terms for re-authorizing the Prescription Drug User Fee Act. At the
same time, the FDA was busy congratulating itself on its performance in approving
new drugs, both in its annual performance report to Congress and in a speech
by Commissioner David Kessler.
Perhaps unnoticed were two concurrent events: the approvals
of CellPro's Ceprate SC System to purify stem cells for bone marrow transplantation
and Elan's Athena Neurosciences subsidiary's Zanaflex tizanidine as an oral
treatment for muscle spasticity (see BioCentury Dec. 9).