FDA Rule on Fixed-Dose Combination Drugs Set for This Year

May 29, 2015

The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released last week.

The rule will also clarify the kinds of studies sponsors need to demonstrate that they’ve met the requirements for fixed-dose combination drugs.

The FDA also wants to extend the regulations to combinations of biological drug products and drug-biologic combinations and clarify when they would apply to certain natural source and synthetic drugs.

The proposed rule will also explain when sponsors can apply for waivers.

Also this year, the agency plans to finalize a rule updating requirements for submission dates and certification and verification of citizen petitions relating to ANDAs and 505(b)(2) applications relying on published data about a third party’s drug.

The two rules join 21 others targeted in November in a Unified Agenda for completion this year, including proposed and final rules on minimum good manufacturing practices for large compounders, reporting interruptions or discontinuances in manufacturing before they become shortages, and administrative authority to destroy drug imports turned away at U.S. borders.

View the spring 2015 list at www.fdanews.com/05-22-15-unifiedagendaspring2015.pdf  — Lena Freund