The president's fiscal 2019 budget plan calls for $5.8 billion in total FDA funding, $1 billion more, or 22 percent, above the agency's fiscal 2017 enacted spending limit, and $663 million, or 13 percent, above the annualized 2018 continuing resolution. The total number reflects an increase of $190 million in user fees and $473 million in tax dollars. With an appropriation of nearly $1.84 billion, the Center for Drug Evaluation and Research would see the largest hike in FDA spending, but most of that would come from user fees for prescription drugs, generics, biosimilars and outsourcing facilities.

The FDA released a draft guidance on the standardized format for electronic submission of NDA and BLA content for the planning of bioresearch monitoring (BIMO) inspections. The draft is being issued along with the BIMO Technical Conformance Guide to address pivotal studies used to support safety and efficacy claims in NDAs and BLAs regulated by the Center for Drug Evaluation and Research, as well as supplemental applications containing new clinical study reports.