Month: November 2016

Hyman, Phelps & McNamara, P.C. ("HP&M") has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers …

By Kurt R. Karst, John R. Fleder & Robert A. Dormer – The current FDA system to announce hotly contested generic drug approval decisions is broken.  As we see it, FDA’s “system” pleases no one and does not appear to be legally mandated.  Moreover, whatever advantage …

By Jennifer M. Thomas –  Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the …

By James E. Valentine & Karla L. Palmer –  There are a number of lists that are central to FDA’s regulatory framework for the regulation of pharmacy compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetics Act (FD&C Act). In recent posts, …

That will be among several food policy topics discussed this Friday at a Food and Drug Law Journal Symposium titled Law and Food Systems: Institutional Pathways Toward a New Paradigm?  Proposals for a single food agency have bubbled up over the years, and the impending election …

Technology continues to change the landscape of healthcare and companies are seeking new and innovative ways to leverage advances in other fields to improve quality of care and the diagnosis and treatment of disease. In doing so, they are required to navigate an increasingly complex …