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Disease-Specific Drug Development Guidances Coming From US FDA In 2018

 
• By Brenda Sandburg

Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.

Vintage typewriter with To Do list for 2018

The US FDA's guidance to-do list for the year has a unique focus on development of drugs for specific diseases. The lineup includes guidances targeting six diseases, including early Alzheimer's disease, amyotrophic lateral sclerosis, migraine and opioid dependence.

FDA Commissioner Scott Gottlieb announced at a meeting in September that the agency would begin work on new disease specific development guidance documents over the next year

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