FDA Doubles Estimated Time Needed For DMF Completeness Assessment
This article was originally published in The Gold Sheet
FDA now says Type II active ingredient drug master files should be submitted six months before the referencing ANDA to allow enough time for the completeness assessment. Delays could mean refuse-to-receive action for the ANDA.
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As the grace period nears its close, industry officials say they expected problems getting generic drug manufacturing facilities to self-identify under the new user fee requirement; meanwhile, FDA expects to hire nearly three times the staff in the Office of Generic Drugs to meet GDUFA commitments.
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.
Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.