, 8 tweets, 2 min read Read on Twitter
THREAD: we’ve received questions from reporters and others related to the generic drug review program at #FDA; and what review activities will continue during the shutdown. I want to provide some information related to these inquiries:
During the lapse period, FDA will not accept generic drug submissions that require payment of a fee (e.g., Abbreviated New Drug Applications (ANDAs))
FDA will accept generic submissions for which no fee is required, if product is within the scope of the GDUFA program. These submissions include, for example: CBE supplements and prior approval supplements to approved ANDAs, Amendments, Annual reports, Applications for PET drugs
Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees. FDA will accept Drug Master Files, including Type II Active Pharmaceutical Ingredient DMFs, intended to be referenced in generic applications
FDA will not conduct initial completeness assessments on Type II API DMFs for which the fee has not been paid and these new DMFs will not be placed on the Available for Reference List.
If a generic drug application references, for the first time after Dec 22, 2018, a Type II API DMF for which the fee has not been paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days.
If the fee is not paid within 20 calendar days of that notice, FDA will not receive the application. At this time, FDA has not determined what approach it will take if the 20 calendar day period expires during the lapse period.
Type II API DMF fees should not be submitted during the lapse period because FDA cannot accept the fees. Fees that are due during the lapse period may be paid as soon as the lapse period ends.
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