Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more
This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. Make no mistake, I have an interest in this...more
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more
On December 3, 2018, the Federal Trade Commission (“FTC”) submitted a comment on the Food and Drug Administration’s (“FDA’s”) revised draft guidance regarding the process for reviewing 505(q) citizen petitions (“Revised Draft...more