By James P. Ellison – FDA’s November 12, 2008 Federal Register Notice of its Direct Final Rule to comply with the Federal Civil Penalties Inflation Adjustment Act, 28 U.S.C. § 2461 note, is not in itself a blogworthy event, but it could be part of …
By Jeffrey N. Wasserstein – First, it was the son of the former Nigerian dictator who wanted my bank account information (I’m still waiting for the bank transfer, by the way!). Now, apparently FDA “special agents” are in on the act. In a scam originating out …
By Ricardo Carvajal & Diane B. McColl – FDA has announced a pretest of a survey instrument designed to gather information about five issues relevant to modernization of the food CGMP regulations at 21 C.F.R. Part 110. The food CGMP regulations are essentially unchanged since …
By Dara Katcher Levy & Ricardo Carvajal – On November 12, 2008, FDA issued an Import Alert on all food containing milk products from China. The Import Alert was issued because of concerns over melamine contamination of China’s milk products, including Chinese infant formula, which …
By Kurt R. Karst – On November 12, 2008, the U.S. Supreme Court issued its opinion in Winter v. Natural Resources Defense Council, Inc. The case concerns the Navy’s power to use “mid-frequency active” sonar in military training exercises. The Court, dividing 6-3 (Chief Justice …
By Jeffrey N. Wasserstein & William T. Koustas – On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial problems in our health care system. The paper, titled “Call to Action: Health Reform 2009” …
By Michelle L. Butler – We previously posted on the expanded certification requirements mandated by section 102(a)(1) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”). Today, the Consumer Product Safety Commission (“CPSC”) published on its website an immediate final rule regarding these certification …
By James R. Phelps – On November 7, 2008, the First Appellate District in the Court of Appeal of the State of California, which sits in San Francisco, issued a remarkable decision in Conte v. Wyeth, Inc. The court said: “We hold that the common law …
By Ricardo Carvajal – According to a web site set up by GAO to aid the 2009 congressional and presidential transition, the need to revamp oversight of food safety is one of several pressing issues that demand urgent attention. Since the early-1990’s, GAO has issued …
By Carrie S. Martin – On October 16, 2008, the U.S. District Court of the District of Columbia issued an opinion in Hays v. Leavitt holding that the “least costly alternative” policy implemented by the Centers for Medicare and Medicaid Services (“CMS”) was contrary to …
By Bryon F. Powell – On November 4, 2008, the United States District Court for the Middle District of Florida granted Defendants AstraZeneca’s and Parexel’s Motions to Dismiss in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP. In this case, the Plaintiffs, various union …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit issued its opinion in Teva Pharmaceuticals USA, Inc. v. Leavitt. The case concerns the availability of 180-day exclusivity for a generic version of Janssen Pharmaceutica’s schizophrenia drug …
By Kurt R. Karst – Answer: "October 24, 2008" . . . . queue Jeopardy! think music . . . . Question: "What is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product?" Alex Trebek: "Correct!" On …
By Ricardo Carvajal – FDA recently published a notice of a proposed collection of information that solicits comments on the use of its new electronic system, called MedWatchPlus Portal, for the collection, submission, and processing of adverse event reports and other safety information for all …
By Diane B. McColl & Ricardo Carvajal – FDA has published a final rule and a draft Compliance Policy Guide (“CPG”) on prior notice of imported food shipments under the Bioterrorism Act of 2002 (“BT Act”). The final rule and draft CPG are available here. …
