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Hyman Phelps McNamara P.C. Document Search Results (257) Show: results per page Sort by:  | First Amendment Argument Fails in Appeal of Wire Fraud Conviction
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 8, 2013, previously published on March 5, 2013 On March 4, 2013, less than three months after oral argument, the Ninth Circuit issued its ruling in United States v. Harkonen, a closely watched case implicating First Amendment issues in the off-label promotion context. As we previously reported, in 2009, a jury had convicted Harkonen of wire...
| | The Hammer Falls on PCA; Indictment Could Raise Difficult Questions About Supplier Verification Under FSMA
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 7, 2013, previously published on February 25, 2013 The U.S. Department of Justice ("DOJ") announced the indictment of former officials of the Peanut Corporation of America ("PCA") for their alleged role in the distribution of peanut products that were implicated in a 2008-2009 national outbreak of salmonellosis. In part, the...
| | U.S. Supreme Court Asked to Review Hatch-Waxman “Safe Harbor” LOVENOX Method Patent Case
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 7, 2013, previously published on February 25, 2013 In a widely anticipated move, Momenta Pharmaceuticals, Inc. and Sandoz Inc. have petitioned the U.S. Supreme Court to review the August 3, 2012 judgment of the U.S. Court of Appeals for the Federal Circuit, in which a divided (2-1) Federal Circuit panel ruled that the scope of the Hatch-Waxman...
| | GAO Report Assesses State Approaches to Control Pseudoephedrine
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 7, 2013, previously published on February 26, 2013 The Government Accountability Office (“GAO”) has issued a report assessing the approaches states have taken to restrict the sales of pseudoephedrine (“PSE”), an ingredient commonly found in over-the-counter cold and allergy medications and a primary ingredient in...
| | Rebel Without a Cause: Sun Sues FDA Over 180-Day Exclusivity for Generic ZOMETA
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 7, 2013, previously published on March 3, 2013 Finally! A Hatch-Waxman lawsuit that is not overly complex and not difficult to unravel. Late last week, Sun Pharma Global FZE, Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceuticals Industries, Ltd. (collectively “Sun”) filed a Complaint and a Motion for a Temporary...
| | FDA Issues Proposed Rule Affecting Acceptance of Data from Medical Device Clinical Studies
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 7, 2013, previously published on February 25, 2013 FDA issued a proposed rule to amend its regulations on acceptance of data from medical device clinical studies. The primary proposed changes include:
| | FDA Issues Draft Guidance, Proposed Rule Regarding Submission of Information on Pediatric Use of Medical Devices
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 7, 2013, previously published on February 24, 2013 The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to require certain medical device submissions to include, “if readily available - (A) a description of any pediatric subpopulations that...
| | FTC’s Interest in Mobile Apps Intensifies
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 25, 2013, previously published on February 22, 2013 As reported in FTC Watch Issue No. 823 (Feb. 13, 2013), the Federal Trade Commission has plans to increase enforcement actions against mobile apps - including mobile medical apps.
| | Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 21, 2013, previously published on February 20, 2013 A recent report from the National Institutes of Health (“NIH”) Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research leaves unanswered questions about the future utility of FDA’s so-called “Animal Efficacy Rule” for NIH-funded research...
| | CSPI Petition Asserts that Sugar-Based Drinks are Unsafe and Requests that FDA Limit “Added Sugars” in Beverages
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 20, 2013, previously published on February 19, 2013 On February 13, the Center for Science in the Public Interest (“CSPI”) together with a coalition of 10 public health departments, 20 national health organizations, and 41 health and nutrition experts, submitted a 55-page petition to FDA requesting that FDA review the generally...
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