By Susan J. Matthees – FDA is withdrawing its draft guidance titled “Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010,” which was published in August 2010. As …
By Kurt R. Karst – Yesterday, we posted on FDA’s report to Congress on encouraging the early submission of citizen petitions covered by FDC Act § 505(q). Today, we take a look at the two annual reports FDA has submitted to Congress detailing the Agency’s experience …
By Kurt R. Karst – On January 24th, the U.S. Court of Appeals for the Ninth Circuit issued its decision in Gaeta v. Perrigo, reversing a decision from the U.S. District Court for the Northern District of California (San Jose Division) that Plaintiff-Appellant Gaeta’s state law …
By Ricardo Carvajal – When FDA issued a report on the Reportable Food Registry ("RFR") 7 months after the RFR’s implementation, the agency cautioned that it was “too early to draw inferences concerning patterns of food and feed adulteration.” Not so in the agency’s first annual …
By Kurt R. Karst – Reports FDA submitted to Congress on the Agency’s implementation of FDC Act § 505(q) recently became available and show that only a few applications have been delayed by certain citizen petitions covered by the law, and that the Agency is timely …
By Ricardo Carvajal – The Government Accountability Office ("GAO") issued a report recommending in part that FDA “identify and request from Congress the authorities needed to access evidence from food companies regarding potentially false or misleading structure/function or other claims on food that would allow the …
On January 23rd, BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs – Why Successful Cures Bring Challenges for …
By Kurt R. Karst – Following the submission of two letters to FDA from both members of the U.S. House of Representatives and the U.S. Senate (see our previous posts here and here) critical of the Agency’s recent characterization of the 12-year reference product exclusivity period …
By Jeffrey K. Shapiro – Yesterday FDA announced that the Center for Devices and Radiological Health (“CDRH”) intends to take 25 actions to improve the 510(k) program in 2011. The full action plan and remarks from CDRH Center Director Jeffrey Shuren, M.D., J.D. can be accessed …
By Kurt R. Karst – In an unpublished, and subsequently sealed, decision handed down earlier this week by Chief Judge Garrett Brown, Jr. of the U.S. District Court for the District of New Jersey, the court dismissed without prejudice an Amended Complaint filed by Paddock Laboratories, …
By William T. Koustas – We previously reported on the struggle between FDA and Regenerative Sciences, Inc. (“Regenerative”) in which Regenerative challenged FDA’s claim that the company’s stem cell procedure is subject to FDA jurisdiction and regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”) …
By Kurt R. Karst – On January 18th, the U.S. Supreme Court denied Apotex Inc.’s Petition for Writ of Certiorari asking for a review of the U.S. Court of Appeals for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s …
By Kurt R. Karst – In a Complaint for Declaratory Judgment filed in the U.S. District Court for the Eastern District of Michigan (Southern Division) last week by Apotex Inc., the company is trying to trigger 180-day exclusivity for generic LEXAPRO Tablets. Apotex heavily relies on …
By Susan J. Matthees – FDA is announcing that it is taking steps to reduce the maximum dosage strength of acetaminophen in prescription combination products to 325 mg in a single dosage unit. The Agency will also require safety labeling changes, including a boxed warning, for …
By Ricardo Carvajal & Wes Siegner – As we would wager is true of all major pieces of legislation, the Food Safety Modernization Act (“FSMA”) can be expected to have significant unanticipated consequences. By way of background, the FSMA requires all food facilities subject to registration …
