New Animal Drug Applications: An Analysis of Approval Rates, Approval Times, and Deficiencies from 1972 through 1981

摘要

This report presents findings on approvals and approval times of New Animal Drug Applications (NADAs) submitted from 1972 to 1981 as well as deficiencies found in NADAs submitted during 1978 and 1979. NADAs submitted during 1972 to 1981 had an overall approval rate of 37 percent. Single NADAs had higher approval rates than combination NADAs; non-food NADAs had higher approval rates than food NADAs. The report also shows that applicants submitting more NADAs have higher approval rates. The report identifies 773 deficiencies in 67 NADAs. The majority (81 percent) of the NADAs have deficiencies in the chemistry and manufacturing portion of the application.