The FDA finalized its 2011 draft guidance on developing drugs to treat or prevent neglected tropical diseases of the developing world. The final guidance gives an overview of nonclinical and clinical development considerations, as well as regulatory paradigms. Changes from the draft guidance include descriptions of new regulatory designations such as "breakthrough therapy" and a "qualified infectious disease product."

The NIH is taking its Alzheimer's research to the next level, awarding about $24 million in grants to scientists at eight academic medical centers who will analyze how genome sequences may contribute to increased risk or protect against the disease. The goal is to find ways to treat and prevent Alzheimer's disease by 2025.

Keeping up with its obligations under the FDA Safety and Innovation Act (FDASIA), the FDA issued its strategic plan for accelerating the development of drugs and medical devices to treat rare diseases in children. The plan, released last week, outlines four agency objectives and promises a number of guidances on the subject.