Chronic pain and fibromyalgia: the regulatory perspective.
Chronic pain is an important clinical entity that represents a currently unmet medical need. Relief of pain is an important public health goal for patients of all ages, from perinatal to geriatric. This article will describe some of the current regulatory issues in developing and approving drugs to treat chronic pain. It will also begin to familiarize the reader with the importance of the so-called 'label' and some of its roles to enable the best 'risk-benefit' decisions be made for, and by, patients with chronic pain.
Witter
James
J
Division of Anti-inflammatory, Analgesic and Ophthalmic Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA.
Simon
Lee S
LS
D000700:Analgesics / Q000627:therapeutic use*; D002908:Chronic Disease; D017277:Drug Approval; D004348:Drug Labeling; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D010003:Osteoarthritis / Q000188:drug therapy; D010146:Pain / Q000188:drug therapy*
D000700:Analgesics