By Jennifer D. Newberger – An increasing number of devices employ radio frequency wireless technology. This trend is likely to continue. These devices present some new technological issues. To respond to these new issues, FDA has just released a draft guidance titled, “Radio Frequency Wireless …
By Wes Siegner – In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education …
By Etan Yeshua – Earlier this week, FDA provided new insight into its interpretation of the definition and regulation of medical foods — a legal category established by the Orphan Drug Act of 1988, incorporated into the Federal Food, Drug, and Cosmetic Act in 1990, and …
By Ricardo Carvajal – Fred Kummerow, a Professor Emeritus at University of Illinois, sued FDA for failing to respond to his citizen petition (Docket No. FDA-2009-P-0382) asking the agency to ban partially hydrogenated oils containing artificial trans fat. The citizen petition was submitted in August …
By Anne K. Walsh – Refusing to give up his fight to overturn his felony conviction, the former CEO of InterMune Inc., Dr. Scott Harkonen, recently filed a petition asking the U.S. Supreme Court to review his case. Harkonen asserts that the government violated his …
By Kurt R. Karst – Five-year New Chemical Entity (“NCE”) exclusivity issues are hot – really HOT – these days! Not only are there three Citizen Petitions pending at FDA requesting that the Agency interpret the FDC Act to grant 5-year exclusivity for a fixed-dose …
By John R. Fleder – For many years, FDA has taken the public position that nongovernmental entities cannot enforce the Federal Food, Drug, and Cosmetic Act. That position has not deterred lawsuits against businesses under statutes other than the FDCA, arguing that the defendants’ conduct violated …
By James R. Phelps – The Federal Register on July 10th published certain recommendations of the Administrative Conference of the United States, including one that independent regulatory agencies should prepare cost-benefit analyses for proposed and final regulations. This was very timely, coming just as I was …
By Riëtte van Laack – The Organic Foods Production Act requires that the U.S. Department of Agriculture (“USDA”) establish national standards for the production and handling of organic products to assure that agricultural products marketed as organic meet consistent uniform standards. USDA established the National Organic …
By Kurt R. Karst – Last Friday, Representative Jason Chaffetz (R-UT) introduced H.R. 2985, the Combination Drug Development Incentive Act of 2013. The bill would amend the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act that affect the submission and approval of …
By Ricardo Carvajal – FDA published a final rule implementing the directive in the Food Allergen Labeling and Consumer Protection Act ("FALCPA") to define the term “gluten-free” (and other terms that FDA regards as equivalent, namely “no gluten,” “free of gluten,” and “without gluten”). The threshold …
By Karla L. Palmer – The General Accountability Office (“GAO”) recently released its Report on Drug Compounding as Congress faces dueling compounding bills in the Senate (S. 959, Pharmaceutical Compounding Quality and Accountability Act, sponsored by Sen. Tom Harkin) and the House of Representatives ( H.R. …
The American Conference Institute (“ACI”) will be holding two events in the coming months that are of particular interest to FDA Law Blog readers. . . . and, importantly, for which our readers can get a discount. The first event is ACI’s Legal, Regulatory, and …
By Allyson B. Mullen – You may recall that French device maker PREVOR previously sued, and won, in litigation against FDA regarding FDA’s classification of Diphoterine® Skin Wash (“DSW”), a product used in industrial settings as a “first response” method to minimize chemical burns. Hyman, …
By Kurt R. Karst – Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …
