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# PDUFA 6 Policy Changes Outlined
- URL: https://www.fdaweb.com/pdufa-6-policy-changes-outlined/
- Published: 2018-05-15T12:00:00.000Z
- Updated: 2026-09-15T00:05:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141438

In preparation for the August distribution of PDUFA 6 FY 2019 program fee invoices, FDA has contacted drug manufacturers outlining policy changes under PDUFA 6 and seeking updated contact information. Policy changes described in the [document](https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM607599.pdf?ref=fdaweb.com) affect **(1)** what prescription drug products are considered to be the “same product as another product” for the purpose of the program for fee exception and **(2)** what products are considered to be separate prescription drug products subject to separate program fees.

Companies are asked to review their contact information and list and confirm their NDA prescription drug products in the *Orange Book*. They also are to confirm biological products on the CDER and CBER lists.