Fast FDA Approvals Of User-Fee NMEs In 1994

The US Food and Drug Administration has announced that the 14 New Molecular Entities which it approved during the last calendar year to which user fees applied were dealt with within an average time of 12.8 months, which is 52% less than the average of 26.5 months for the 25 NMEs approved by the agency in 1993.

Seven of the 14 NMEs approved last year to which user fees applied were cleared by the agency within 12 months or less. Under the Prescription drug User Fee Act of 1992, such fees are required for prescription pharmaceutical products submitted to the agency for approval on or after September 1, 1992.

A total of 22 NMEs were approved by the FDA last year, a drop of three on the previous year's total. However, 12 of these, or 55% of the total for 1994, were classified as priority drugs, compared with 52% and 42% of the total in 1993 and 1992 respectively. The average times taken to approve priority drugs dropped to 14.7 months last year from 19.2 in 1993, while for standard NMEs the average time in 1994 was down 68% compared with 1993 at 10.7 months.