FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws
This article was originally published in The Tan Sheet
Roughly half of the 74-day "issue" letters sent by FDA to NDA applicants in the first six months of the agency's 2003 fiscal year have noted application flaws, Office of New Drugs Director John Jenkins, MD, said at Temple University's annual industry/FDA conference in Philadelphia April 15
You may also be interested in...
FDA should consider issuing "refuse-to-file" decisions more often for incomplete or inadequate NDAs, the HHS Inspector General recommended in a report released March 25
FDA is planning a prospective study on the root causes of multiple-cycle drug and biologic reviews as part of an effort to improve the review process, Commissioner Mark McClellan, MD/PhD, announced Jan. 31
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC