Gottlieb: New Guides Show Effort To More Concisely Communicate Advice

FDA published five neurological disease-specific guidance documents as part of its efforts to clearly communicate scientific and regulatory information more efficiently through practical, more concise guidance, FDA Commissioner Scott Gottlieb announced Thursday (Feb. 15). The agency plans to continue issuing disease-specific guidances, including some focused on opioid dependence and addiction, the agency chief added. The guidance documents released Thursday provide information on developing drugs for amyotrophic lateral sclerosis (ALS); partial onset seizures in children 4 years old or younger; Duchenne...