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 …
By Riëtte van Laack – In March 2012, in a consumer action against Jamba Juice, filed in California, plaintiffs asserted, among other things, that steviol glycosides should not be considered natural because of the “chemical processing” used to extract them. Earlier this month, another lawsuit concerning …
By Kurt R. Karst – A series of decisions handed down earlier this week by Judge Mary Jane Bowes of the Superior Court of Pennsylvania arising from mass tort litigation in Philadelphia County involving REGLAN (metoclopramide) and its generic versions can only be drescibed as …
By Ricardo Carvajal – Last Friday, FDA released two additional proposed rules that are fundamental to the agency’s implementation of the Food Safety Modernization Act (FSMA): Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule) and Accreditation of Third-Party Auditors/ …
By James E. Valentine* & Alexander J. Varond – Since the breakthrough therapy designation came into existence a year ago, drug companies (and their investors) have been trying to figure out the value of the program. The designation was initially proposed as a way to …
By Kurt R. Karst – FDA’s recent approval of Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco’s”) ANDA No. 077571 for a generic version of PRANDIN (repaglinide) Tablets is interesting on several fronts. For starters, it is the ANDA at the heart of the U.S. Supreme Court’s decision …
By JP Ellison – Last week, John Roth, the Director of FDA’s Office of Criminal Investigations posted on FDA’s blog, FDA Voice. His post concerned a criminal case that had interested us about a Montana resident who had pled guilty and been sentenced on a …
By Kurt R. Karst – In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision …
