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 …
By Riëtte van Laack – As previously reported here, on Dec. 8, 2010, FDA issued a proposed rule to amend the interim final rule (“IFR”) for the phytosterol health claim. In the preamble to that proposal, the agency stated its intent to discontinue its policy of …
By Kurt R. Karst – In a Complaint lodged against the U.S. Patent and Trademark Office (“PTO”) in the U.S. District Court for the Eastern District of Virginia last September, but only recently served, the Genetics & IVF Institute (“GIVF”) is challenging the PTO’s August 2010 …
Hyman, Phelps & McNamara, P.C.'s Jeff Shapiro published an article in this month's MD&DI magazine - What Happens to Medical Device Reports Once They Reach FDA? In the article, he summarizes a Office of Inspector General Report finding that FDA has not used medical device reporting …
By Ricardo Carvajal – The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its First Annual Workshop on Food and Supplements on February 17 in Atlanta. Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be …
By Kurt R. Karst – In a January 7th letter sent to FDA Commissioner Margaret Hamburg, a group of four U.S. Senators take exception to FDA’s recent characterization of the 12-year exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as …
By David B. Clissold – Last week, FDA released Agency's first guidance for tobacco product manufacturers concerning the introduction of “new” tobacco products. The guidance was issued in final form since some manufacturers will need it to help them submit reports to FDA over the next few months. A “new …
By Kurt R. Karst – Last Friday, 32 State Attorneys General filed an amicus brief with the U.S. Supreme Court asking the Court to grant the Petition for Writ of Certiorari filed last month by a group of drug purchasers in Louisiana Wholesale Drug Co., Inc., …
By Susan J. Matthees – Last week, FDA announced that the Agency has adopted final amended informed consent regulations. As we noted last year, the Food and Drug Administration Amendments Act ("FDAAA") § 801(b)(3)(A) required that FDA amend the informed consent regulations set forth at 21 C.F.R. § …
By James R. Phelps – California's SB 657, adopted in 2010, enlists manufacturers and retailers of goods with annual worldwide gross receipts over $100 million in the effort to eradicate “slavery and human trafficking.” They are to provide information on …
By Kurt R. Karst – In a notice slated for publication in the January 7th Federal Register, FDA is seeking to end the continued marketing of many unapproved oral prescription drugs for the relief of cough, cold, or allergy. The action will likely affect hundreds of …
By Riëtte van Laack – More than 9 years after issuing a proposed rule, the Food Safety and Inspection Service (“FSIS”) published the final rule for nutrition labeling of single-ingredient meat and poultry products, as well as ground and chopped meat and poultry products. Starting January …
By Ricardo Carvajal – The Food Safety Modernization Act ("FSMA") is now law. We previously blogged on some provisions that take immediate effect (namely stronger records access authority under FDC Act § 414, mandatory recall authority, whistleblower protection, and authority to refuse admission of imported food …
