FDA Projects More And Faster Approvals In 1996

The US Food and Drug Administration says it expects to review a total of 242 New drug applications during fiscal 1996, compared with an estimated total of 220 in fiscal 1995, and that it will approve 84 NDAs in fiscal 1996, compared with a total of 76 in in the present financial year and 69 in fiscal 1994 (out of 201 NDA applications made during that year).

The agency has made these projections in its budget request document, entitled Justification of Estimates for Appropriations Committees. In it, it also forecasts that average approval times for NDAs during fiscal 1996, from receipt to approval, will be reduced to 21.5 months, compared with an average of 24.2 months in fiscal 1995 and 26.3 months in the previous year.

The number of Abbreviated NDAs to be reviewed by the agency in fiscal 1996 will advance to 309, according to the request document, compared with an estimated 281 in the current financial year and 255 in fiscal 1994. Moreover, the average time taken by the agency to review NDAs is expected to decline from 24 months this year to 20 months.