By Ricardo Carvajal – According to one working definition, synthetic biology encompasses "the design and fabrication of biological components and systems that do not already exist in the natural world" and "the re-design and fabrication of existing biological systems." Recent developments in the field prompted …
By Kurt R. Karst – Responding to a request from certain Members of Congress, the U.S. Government Accountability Office (“GAO”) has released a report evaluating FDA’s use of evidence from non-inferiority trials to establish a drug’s effectiveness and support approval of new therapies. As …
By Riëtte van Laack – In anticipation of the possible approval of the New Animal Drug Application (“NADA”) for genetically engineered AquAdvantage Salmon (“GE salmon”), FDA announced a public hearing on September 21, 2010, concerning the labeling of food made from such salmon. This is …
By Oisin A. Mulvihill* & Peter M. Jaensch – A recent string of high-profile pharmaceutical and medical device product recalls appears to be reigniting FDA’s interest in pressing misdemeanor charges against corporate executives under the Responsible Corporate Officer Doctrine, or Park Doctrine. Lewis Grossman, professor …
By Ricardo Carvajal – In several cases that challenge food marketers’ use of the term “natural” in labeling and advertising, the presiding judges have recently opted to suspend proceedings and seek an administrative determination from FDA as to whether high fructose corn syrup ("HFCS") qualifies …
By Kurt R. Karst – When we attended the August 17th hearing in Sanofi-aventis U.S. L.L.C.’s (“Sanofi’s”) challenge to FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s LOVENOX (enoxaparin sodium injection), it seemed as …
By Susan J. Matthees – FDA announced yesterday the availability of two new draft guidance documents regarding implementation of the menu labeling provisions of section 4205 of the Patient Protection and Affordable Care Act (“PPACA”). As we reported last month, FDA requested comments on how …
By Ricardo Carvajal – FDA announced a public workshop intended to help the agency gather information on the safety and effectiveness of medical devices that use nanotechnology. FDA posted questions on its website that focus on manufacturing, characterization, and biocompatibility issues of the sort that …
By Diane B. McColl – According to Sharon Benz, Ph.D., Director of the Division of Animal Feeds in FDA's Center for Veterinary Medicine ("CVM"), CVM is moving away from enforcement discretion for new animal feed/pet food ingredients. In a conversation with HP&M's Diane McColl, Dr. …
By Jamie K. Wolszon – FDA announced on August 19, 2010 in the Federal Register that the agency is reopening the comment period for comments related to FDA oversight of laboratory-developed tests ("LDTs"), and will now accept comments until September 15. The comment period had closed …
In the July/August 2010 edition of FDLI Update, HP&M attorneys John R. Fleder and Cassandra A. Soltis authored an article, titled “Advertising and Promotion: FDA Is Not the Only Cop on the Beat.” The article focuses on the various non-FDA groups that police alleged false …
By Kurt R. Karst – When does a patent expire? When does pediatric exclusivity begin and end? And when can FDA approve ANDAs (or 505(b)(2) applications)? These are some interesting questions touched on in some recent court decisions. But before we get to those …
By Carrie S. Martin – Yesterday, the Federal Trade Commission (“FTC”) held a press conference in Chicago to announce a lawsuit against several companies, including Central Coast Nutraceuticals, iLife, Simply Naturals, Fit for Life, and Health and Beauty, for their marketing of acai berry weight-loss …
By Kurt R. Karst – On August 16, 2010, FDA announced that the Agency plans to follow through on previous correspondence threatening to withdraw approval of all marketing applications for the Subpart H (accelerated approval) drug Midodrine HCl. FDA also issued a Notice of …
By Kurt R. Karst – A recent analysis of the Congressional Budget Office’s (“CBO’s”) cost estimate of legislation intended to curb patent settlements (or what opponents call “pay-for-delay” or “reverse payment” agreements) criticizes the estimated savings as “significantly overstated.” As we recently reported, in late …
