FDA releases 2018 policy roadmap
FDA this year will create new incentives for biosimilars development, release a suite of guidance documents on developing treatments for neurodegenerative disorders and explore creation of a new expedited approval framework. The agency announced the plans in a Policy Roadmap released Thursday.
The roadmap highlights policy priorities for 2018 across the agency. It describes previously announced policy initiatives, including steps FDA will take to ameliorate the opioid abuse epidemic, measures to make drug markets more efficient through promoting greater generic drug competition, and plans to push promising medicines to patients more quickly. It also hints at new measures, such as tasking FDA with updating generic drug labels and making more information from medical product reviews public...