FDA, EU Likely to Increase Use of Special Designations to Speed Approvals in 2013, Tufts Says

U.S. and EU regulators hope to increase the use of special designations, such as fast track, priority review and accelerated approval, to speed approvals of drugs for non-cancer diseases that are rare and/or life-threatening, according to a new Tufts report.

Regulators want to approve these products at the same levels oncology drugs enjoyed between 2007 and 2011. During this period, oncology drugs accounted for about 38 percent of all orphan approvals in the U.S. and Europe, according to the Tuft’s Center for the Study of Drug Development 2013 Outlook. The report offers the center’s predictions on near-term pharmaceutical development trends. 

Expected changes in regulatory policies and programs, such as the FDA’s new breakthrough designation, and a shift in market value assessment that favors R&D for special patient populations may increase the popularity of specialty designations besides the orphan designation, Tufts said.

Enforcement activities, practices and even staff are changing around the globe. The day-to-day routine drugmakers are used to when dealing with international regulators is changing and to be successful, you will need to know as much as possible.

With FDAnews’ Guide to International Pharma Regulation: 2013 Edition, you will receive briefs on regulatory developments affecting pharmaceutical production in more than 45 nations around the world. You also gain access to a compilation of more than 150 reports highlighting changes from the past year that could supercharge your international sales.

To compete internationally, you must comply internationally. It’s a lesson your competitors have learned. Don’t get left behind. Place your advance order now.