FDA Asks Drugmakers to Report PDUFA-Eligible Products, Orange Book Changes

August 17, 2017

In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any PDUFA eligible products and Orange Book changes involving their products by the end of August.

In a “Dear Colleague” letter, the agency called on drugmakers to verify all contact information and PDUFA user fee-eligible products by August 15, and to indicate any products they do not believe should be assessed fees under PDUFA.

The letter further calls on companies to review their current list of drug products in the FDA Orange Book, and to notify Orange Book staff of any changes — such as drug products the company no longer markets — by August 31. They should also send a courtesy copy of any changes to the agency’s user fee staff.

Notifications of changes sent after August may lead to a product’s inclusion on the invoice for the next fiscal year. In such cases, the manufacturer may be eligible for a refund of the assessed user fee.

In addition, manufacturers should confirm all user fee-eligible biological products on the CDER and CBER lists by August 31, and notify the appropriate center of any changes that need to be made.

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