Exclusivity Rules Blog — Welcome
Welcome to the new Exclusivity Rules blog, sponsored by Lassman Law+Policy. As the name suggests, this blog will focus on the complex rules – both written and unwritten – that govern FDA’s exclusivity...
View ArticleSubmarine Exclusivity: Unseen Risk for 505(b)(2) Applications
Last week, the Food and Drug Administration (FDA) finalized its guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application. The final guidance provides useful tips on the differences...
View ArticleOrphan Drug Designation: The Gift That Keeps on Giving
In the world of exclusivity, there is one overarching rule: all good things must come to an end. New chemical entity (NCE) exclusivity expires after five years (sometimes four); orphan drug exclusivity...
View ArticleCourt Drops Depth Charge on Submarine Exclusivity
On July 22, 2019, the United States District Court for the District of Columbia ruled against the Food and Drug Administration (“FDA”) in a lawsuit challenging FDA’s application of 3-year exclusivity...
View ArticleNCEs+Old Antibiotics: The Wrong Combination?
For many things in life, details matter. Take cooking, for instance: add the wrong ingredient or combine your ingredients in the wrong order, and you may have an unexpected disaster rather than a...
View Article180-Day Exclusivity: When Everybody’s Special, Nobody’s Special
It is very unusual for a Hatch-Waxman exclusivity issue to intersect with a Pixar movie. But a recent viewing of The Incredibles got me thinking about FDA’s 2016 final regulation regarding 180-day...
View ArticleBest Lawyers: Scott M. Lassman Recognized Again for FDA and Administrative Law
Scott M. Lassman recently was recognized again by The Best Lawyers in America as one of the leading lawyers in the United States in the categories of FDA Law and Administrative/Regulatory Law. Best...
View ArticleCongress Should Fix FDA’s Q1/Q2 “Catch-22” Problem
FDA’s Catch-22 Problem Although the generic drug approval process was intended to be streamlined and efficient, Abbreviated New Drug Applications (ANDAs) often run a gauntlet of unnecessary and...
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