Congress Should Fix FDA's Q1/Q2 "Catch-22" Problem
May 5th, 2022
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 senseless regulatory hazards during the review pro…
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Best Lawyers: Scott M. Lassman Recognized Again for FDA and Administrative Law
August 26th, 2021
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 Lawyers’ recognitions are based purely on the…
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Exclusivity Rules Blog — Welcome
April 25th, 2019
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 decisions for drugs and biologics. The blog…
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