FDA chief Scott Gottlieb promises to streamline drug development pathway for biopharma
FDA Commissioner Scott Gottlieb on Tuesday told a House Appropriations subcommittee that the agency plans to “sharply increase” its release of disease-focused guidance documents to help drugmakers develop new treatments.
“Among some of the many areas we’re working on right now are new guidance to lay out modern criteria for the development of drugs targeted to ulcerative colitis; rare pediatric cancers; pediatric HIV; and serious, life-threatening and non-cancer blood disorders like aplastic anemia,” according to Gottlieb’s written testimony on the 2019 budget.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.