Tag: Food and Drug Administration (FDA) ⋅ Page 1

Professor Lietzan speaks to Akron law students about perils of patent reform

At a recent event at the University of Akron School of Law, Professor Erika Lietzan spoke about what she called the “assault on drug patents,” including patent reform activity in Congress as well as proposals to prevent drug companies from patenting any changes or improvements to their drugs after approval (so called “one and done” proposals).  She explained that medical…

Professor Lietzan continues to write about the FDA regulation of CBD products

In a recent editorial for Drug Discovery Today, “A special exception for CBD in foods and supplements?”, Professor Erika Lietzan and co-author Patricia J. Zettler,  write about the emerging cannabidiol (CBD) market. They explain that most foods and dietary supplements containing CBD – even CBD from hemp — violate FDA’s “drug exclusion rules.” FDA has not been taking enforcement action,…

Professor Lietzan Named a “Best Lawyer in America”

Professor Erika Lietzan has again been named a “Best Lawyer in America”  in both FDA Law and Biotechnology & Life Sciences. This marks the sixth year in a row for FDA Law and the twelfth year in a row for Biotechnology Law. The Best Lawyers honor is meant to identify the top 5 percent of practicing attorneys in the United…

Professor Lietzan Presents Paper at Law and Biosciences Workshop

On May 6, Professor Erika Lietzan presented her most recent paper at Stanford Law School, as part of its Law and the Biosciences Workshop. Her paper, Access Before Evidence and the Price of FDA’s New Drug Authorities, explores the costs of error and delay associated with federal government approval of new drugs, as well as costs associated with other less-studied aspects of…

Professor Lietzan Speaks About Top Cases in Food and Drug Law

On May 3, Professor Erika Lietzan spoke at the annual meeting of the Food and Drug Law Institute (FDLI), a nonprofit organization dating to the 1940s that brings together experts from the federal government, industry, the private bar, non-profit organizations, patient and consumer advocates, consulting firms, and academia. Its annual meeting is the premier conference for the food and drug law community…

Professor Lietzan Lectures on the Hatch-Waxman Amendments

Professor Erika Lietzan recently gave a lecture on the Hatch-Waxman Amendments as part of the Mason Judicial Education Program, a division of George Mason University’s Law & Economics Center (LEC). Professor Lietzan lectured for an hour on the Hatch-Waxman Amendments, which created a statutory pathway for approval of generic drugs as well as provisions governing the timing of that approval…

Professor Lietzan Quoted in Article about CBD

Professor Erika Lietzan was quoted recently in a Philadelphia Inquirer story, “Selling CBD in food is illegal, FDA says. So why are so many retailers selling it?,” about the sale of foods and dietary supplements containing CBD, or cannabidiol, which is derived from cannabis. CBD is reputed to have health benefits, and after FDA approved a new drug containing CBD in…

Professor Lietzan Quoted by CBS News on Pharmaceutical Manufacturing Recall

Professor Erika Lietzan was recently quoted by CBS News in a Moneywatch article relating to pharmaceutical manufacturing, “Drugmaker behind ibuprofen recall has history of FDA violations.” Last month New Jersey drugmaker Tris Pharma doubled its recall of infant ibuprofen, and CBS News spoke with Professor Lietzan about the company’s manufacturing history.  She described some of the “red flags” in a…

Professor Lietzan Presents at Symposium on Federal Regulation of Cannabis

Professor Erika Lietzan presented her most recently completed article at a symposium on federal regulation of cannabis. The symposium, hosted by the Food and Drug Law Institute, convened academics, scientists from the Food and Drug Administration, lawyers from private practice, and industry developing cannabis-based products, to consider the path forward for a federal regulatory regime. Professor Lietzan’s forthcoming article in the American…

Professor Lietzan Receives ‘Best Lawyer’ honors

Professor Erika Lietzan has been named a “Best Lawyer in America”  in FDA Law and in Biotechnology and Life Sciences Law.  This marks the sixth year in a row for FDA law and the twelfth year in a row for biotechnology law.  The Best Lawyers honor is meant to identify the top 5 percent of practicing attorneys in the United…