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.
Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.