Monday, July 28, 1997
WASHINGTON - The FDA's Center for Biologics Evaluation and Research has received as many IND and IDE applications in the first eight months of 1997 as it did during 1996, and it expects the total for the year to set a record, according to CBER Director Kathryn Zoon.Zoon told a meeting of the Food and Drug Law Institute in Washington last week that CBER received 472 INDs and IDEs through June 30, including 280 biotechnology applications, compared to a total of 467 applications in 1996. CBER has received 36 product license applications this year, half of which were biotechnology products, she said. The total for 1996 was 40, of which 8 were biotechnology products.
CBER's 'reinvention' scorecardZoon also told the Food and Drug Law