Neil O’Flaherty has over 28 years of experience involving FDA regulation of medical devices and other products. He has spoken, written and advised extensively on medical device and other FDA-related topics, including the regulation of mobile MORE >see all news >
We support clients throughout the entire lifecycle of products aimed at improving the population's health and wellness: food and beverages, nutritional supplements, cosmetics, medical devices and pharmaceuticals.MORE
Drawing heavily on our IP, patent and trademark expertise, we provide our clients with business advice and strategies that enhance product value and head off future litigation.MORE
We are deeply experienced in FDA and FTC disputes, patent and trademark infringement cases, class actions, breach of contract and unfair competition claims. We are renowned in the area of Paragraph IV litigation, where companies challenge brand name patents so that medications can be marketed in generic forms.MORE
We provide counseling both to generic companies seeking to challenge patents and bring drugs to market, and to brand name pharmaceutical companies seeking to strategically patent and protect their brand name products in the long term.MORE
New Hope Network recently featured an article published by Katie Bond titled, “How to Back Up Advertising Claims and Avoid Risk”. Katie discusses the recent regulatory landscape with respect to advertising law and provides valuable insight into strategies for mitigating risk. To read the full article, please click HERE.
On July 9, 2018, Partners Joseph Cwik and Erin Conway earned a complete victory at the U.S. International Trade Commission (“ITC”) for the firm’s client ECI Pharmaceuticals LLC (“ECI”) when Complainants Valeant Pharmaceuticals North America LLC and Valeant Pharmaceuticals International, Inc. withdrew all allegations in their Amended Complaint against ECI and moved to terminate their […]
ATU DC’s Rend Al-Mondhiry, Katie Bond, and Ivan Wasserman have been featured in a recent article published by Natural Products Insider assessing the potential issues with dietary supplement advertising by the new FTC leadership under the Republican Administration. To read the full article, please click HERE.