NDA Reviews To Be Studied Prospectively To Identify Best First-Cycle Practices
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws
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
FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws
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
FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws
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