ANDA Sponsors May Need Extra Three Months To Avoid DMF-Related Delays
Executive Summary
Under GDUFA, drug master files must pass a completeness assessment before they can be referenced in an ANDA. Sponsors should coordinate better with DMF holders to assure that FDA has adequate review time.
You may also be interested in...
Updated DMF Guidance Reflects GDUFA II
US FDA’s first revision of its foundational Drug Master Files guidance in 30 years contains few surprises but incorporates statutory and regulatory actions. Among the changes: a new section requiring electronic submission of DMFs and a section reflecting GDUFA II completeness assessments in Type II DMFs.
Updated US DMF Guidance Reflects GDUFA II, Electronic Submissions
US FDA’s first revision of its foundational Drug Master Files guidance in 30 years contains few surprises but incorporates statutory and regulatory actions. Among the changes: a new section requiring electronic submission of DMFs and a section reflecting GDUFA II completeness assessments in Type II DMFs.
Generic Sponsors Need To Increase Communications About Drug Master Files, US FDA Says
Industry complaining about issues in DMF completeness assessments, but few sponsors schedule teleconferences after complete response letters, FDA says.