US FDA BEATS 1990 DRUG APPROVALS IN 1991

13 January 1992

In the last few days of 1991, the US Food and Drug Administration approved four new drugs and tied the previous record of 30 set in 1985. This was well ahead of the 23 new drugs approved in 1990.

The median time for new drugs approved in 1991 was 22 months, compared with 24 months in 1990, and 29 months in 1989. The agency has said that it has substantially reduced the approval time for new applications.

Neil Sweig of Brenner Securities agreed with other analysts and industry spokesmen that the credit for this belongs to the new FDA Commissioner, David Kessler. "He has truly lit a fire under the FDA," said Mr Sweig. And a spokesman for the US Pharmaceutical Manufacturers Assoc-iation said that the FDA was headed in the right direction with respect to new drug approvals.

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