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Hyman, Phelps & McNamara, P.C. Document Search Results (257) Show: results per page Sort by:  | FDA Proposes to Harmonize Medical Device Labeling
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 24, 2013, previously published on April 22, 2013 FDA is proposing to amend the medical device labeling requirements to allow for use of internationally recognized stand-alone symbols explained in an accompanying symbols glossary. The symbols glossary would include a list of each symbol used in the device labeling and an explanation of the...
| | FTC Loses Again; Court of Appeals Affirms Lower Court's Determination that Garden of Life's Expert Opinion Constitutes Competent and Reliable Evidence
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 22, 2013, previously published on April 18, 2013 As previously discussed, in 2011, the FTC filed an action against Garden of Life and its owner (collectively “GOL”) asking the District Court to order GOL to show cause why it should not be held in civil contempt.
| | CDRH Working to Update Appeals Guidance for Consistency with FDASIA
Jennifer D. Newberger, Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 22, 2013, previously published on April 17, 2013 The medical device appeals process has long been in need of improvement. There are several ways an entity can appeal a decision of the Center for Devices and Radiological Health (“CDRH”), but the most common of these is by “supervisory review,” described in 21 C.F.R. §...
| | When is a Website Considered Labeling?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 18, 2013, previously published on April 16, 2013 Our colleagues at the Drug and Device Law Blog recently blogged on the decision in Wilson v. Frito-Lay North America, Inc., a false advertising case out of the Northern District of California in which the court held that statements on a food company’s website did not constitute labeling even...
| | “Opioid Spring” Blossoms: FDA Finds “Original” OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAs
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 18, 2013, previously published on April 16, 2013 The cherry blossoms are finally in full bloom in Washington, D.C., and so too is FDA’s thinking on one non-abuse-deterrent drug. In a prepublication version of a notice that will be published in the Federal Register on April 18, 2013, FDA has determined that OXYCONTIN (oxycodone...
| | The HHS Office of Inspector General Reports on Acute-Care Hospitals’ Ubiquitous Practice of Outsourcing High-Risk Compounded Sterile Products
Jeffrey N. Gibbs, Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 17, 2013, previously published on April 16, 2013 On April 10, 2013, the Department of Health and Human Services’ Office of Inspector General (“OIG”) released a Memorandum Report titled, “High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them.” The OIG Report provides information about...
| | FTC Annual Report Highlights Commission Focus on Health-Related Advertising
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article April 16, 2013, previously published on April 15, 2013 As it does every spring, the Federal Trade Commission (“FTC”) has released its annual report. The new report, which covers 2012, makes clear that the FTC remains as focused as ever on health-related advertising ¿ especially where advertising allegedly promotes products for weight...
| | The President’s FY 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity; Biologics Exclusivity Faces Opposition in TPP Talks
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 11, 2013 Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new user fee revenue, making the increase a bit...
| | Generic BAYTRIL Approval Suspended; Bayer Alleges ANADA Approval Violates GADPTRA and APA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 15, 2013 “GADPTRA” - Now there’s an acronym you don’t see very often on this blog. It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman equivalent for generic animal drugs. Our only...
| | Federal Judge Grants Defendants’ Motion for Summary Judgment in “All Natural” Lawsuit
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 10, 2013 On March 28, U.S. District Court Judge Richard Seeborg of the Northern District of California entered summary judgment for the defendants in a 2010 class-action lawsuit which had alleged that defendants misrepresented AriZona Iced Tea beverages containing “man-made” citric acid and high...
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