Inpharma 1379 - 22 Mar 2003

Novel drug discovery technology,mergers cutting down on NDAs

The US FDA believes novel drug discoverytechnologies and pharmaceutical company mergers arecutting down on the number of new drug applications(NDAs), reports the Pink Sheet. According to the report,the agency suggests that the move from traditionalchemistry to biotechnology and the attempt to integrateinformation gained from genomics, proteomics andother emerging areas has resulted in a shift in theparadigm for drug development. In the opinion of theDeputy Director of the Center for Drug Evaluation &Research, there may be a lag period as data from allthese new technologies is processed, says the report.The Deputy Director has also suggested thatcommercial activity during the 1990s, such as variousmergers and lower research and development spending,may have contributed to the current decline in drugapplications. He suggests that other contributing factorsmay be the number of generics already approved inprominent markets and a shift towards developing drugsfor more specific disease states.FDA sees drug discovery tecnology, mergers cutting down on NDAs. FDC Reports- Pink Sheet - Prescription Pharmaceuticals and Biotechnology 65: 27, 10 Mar2003 800925559

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Inpharma 22 Mar 2003 No. 13791173-8324/10/1379-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved