By Jennifer D. Newberger – On June 5, 2012, the Department of Health and Human Services Office of Inspector General (“OIG”) released a report titled “Scientific Disagreements Regarding Medical Device Regulatory Decisions.” A number of scientific disputes at the Center for Devices and Radiological Health (“CDRH”) …
By Diane B. McColl - The days of having to deal with those pesky adhesive labels on citrus fruit may be over. FDA has announced a final rule approving the use of a carbon dioxide laser for etching information, such as product code, on the surface of …
By Kurt R. Karst – In a late-day vote, the U.S. House of Representatives passed H.R. 436, the Health Care Cost Reduction Act of 2012 (formerly titled the Protect Medical Innovation Act of 2012), by a 270-146 vote. Among other things, the bill repeals the medical …
By Kurt R. Karst – Magistrate Judge Theodore H. Katz of the U.S. District Court for the Southern District of New York has dealt FDA another loss in litigation over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals. In …
By Kurt R. Karst – As the U.S. Senate and U.S. House of Representatives geared up last month to consider bills in their respective chambers to, among other things, reauthorize and amend old and establish new user fee statutes, one FTC Commissioner – Commissioner J. Thomas …
Hyman, Phelps & McNamara, P.C. Director Jeffrey N. Gibbs is a featured speaker at the Food and Drug Law Institute’s upcoming Medical Device Regulation and Litigation Conference. The conference is schedule to take place on July 18, 2012 at The Madison Hotel in Washington, DC. A …
By John R. Fleder – It is often said that a grand jury would indict a ham sandwich if asked to do so by a prosecutor. Some lawyers also say that the government cannot lose an FDA misdemeanor prosecution against current and former company officials because …
Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro is the featured presenter in a 90-minute webinar hosted by Elsevier Business Intelligence, titled “Discover the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance.” The webinar is scheduled for June 19, 2012 at 1:00 PM …
By Jennifer M. Thomas – Last week, the Federal Trade Commission (“FTC”) hosted a workshop entitled “In Short: Advertising and Privacy Disclosures in a Digital World.” The workshop was intended to explore whether the FTC needs to revise its online advertising disclosure guidelines (“Dot Com Disclosures”), …
By Ricardo Carvajal - FDA denied a citizen petition submitted by the Corn Refiners Association ("CRA") which asked FDA to authorize the use of “corn sugar” as a common or usual name for high fructose corn syrup ("HFCS"), and to amend certain regulations that reference “corn …
