IND and NDA Filings Rise

May 11, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration?s (Rockville, MD) Center for Drug Evaluation and Research (CDER) received 637 commercial investigational new drug (IND) applications in 2005, a 20-year high.

The US Food and Drug Administration's (Rockville, MD, http://www.fda.gov) Center for Drug Evaluation and Research (CDER) received 637 commercial investigational new drug (IND) applications in 2005, a 20-year high. The number of INDs received has been rising since 2004, when 621 applications were received. The number of noncommercial INDs received in 2005 was 1297, a number within the expected range of the past 20 years.

CDER also received 116 new drug applications (NDAs) in 2005. This continues a trend, which began in 2003, of modest growth in NDAs received. The continuing rise in applications may result from the transfer of therapeutic biologics to CDER in October 2003.

Drug approvals are down, however: FDA approved 20 new molecular entities (NMEs) in 2005: fewer than the 36 approved in 2004.

On May 8, the Tufts Center for the Study of Drug Development reported that the number of drugs entering clinical trials surged 52% in the period 2003-2005. The study examined 10 pharmaceutical companies and signals that the industry may be emerging from its research and development drought. The center is affiliated with Tufts University in Medford, Massachusetts, receives funds from drugmakers, and is a nonprofit group dedicated to developing information to improve the drug discovery and approval process.