Advisory Opinion No. 08-04 (Free Trial Program) Last week, the Office of Inspector General (“OIG”) of the Department of Health and Human Services posted an advisory opinion addressing a free drug trial program for hemophilia A patients (“Proposed Arrangement”). This was the first opinion outside of …
In a recently published white paper (registration required), Steven Richter, a former FDA official and President and Chief Scientific Officer of Microtest Labs, discusses the regulatory challenges facing combination products. The market for combination products is growing such that it is estimated to reach approximately …
On April 30, 2007, the District Court for the Southern District of Illinois issued its opinion in Connell v. Secretary of Health and Human Servs., No. 05-cv-4122-JPG, 2007 WL 1266575 (S.D. Ill. Apr. 30, 2007) concerning a final decision by the Secretary of the Department …
Welcome to the FDA Law Blog, the blog of Hyman, Phelps & McNamara, P.C. We’ll be covering topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law. First and foremost, …
