FDA NDA/BLA Early Input Letters: How Much Should Be Publicly Disclosed?
Executive Summary
FDA is concerned about how companies will communicate information included in the agency's early feedback letters on pending applications, Office of New Drugs Director John Jenkins, MD, said Oct. 8
You may also be interested in...
PhRMA Feels Deadline Pressure, Reminds FDA Of Flexibility In PDUFA Goals
The Pharmaceutical Research & Manufacturers of America is suggesting that FDA can miss its user fee deadline for a product if prolonging the review would lead to swifter approval than entering a second cycle
PhRMA Feels Deadline Pressure, Reminds FDA Of Flexibility In PDUFA Goals
The Pharmaceutical Research & Manufacturers of America is suggesting that FDA can miss its user fee deadline for a product if prolonging the review would lead to swifter approval than entering a second cycle
FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws
About 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