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Hyman, Phelps & McNamara, P.C. Document Search Results (254) Show: results per page Sort by:  | Third Circuit Holds that the FDC Act Preempts Class Action Regarding Absence of Trans Fat and Cholesterol Reducing Effect
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 17, 2013, previously published on May 16, 2013 On May 9, 2013, the U.S. Court of Appeals for the Third Circuit affirmed a District Court’s decision that a state law class action concerning claims regarding the absence of trans fat and cholesterol lowering effect was preempted.
| | FDA Deploys Section 301(ll) in Battle against DMAA
Ricardo Carvajal, A. Wes Siegner; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 17, 2013, previously published on May 16, 2013 A year ago, FDA issued a warning letter to USPlabs alleging that certain products containing dimethylamylamine ("DMAA") that were marketed as dietary supplements were adulterated because (1) DMAA is a new dietary ingredient ("NDI") for which no notification had been submitted as...
| | FDA Determines Original OPANA ER Not Discontinued for Safety Reasons; Decision Affirms Case-by-Case Review
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 16, 2013, previously published on May 13, 2013 Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) Extended-release Tablets approved under NDA No....
| | FDA Announces Public Meeting Regarding Device Modifications
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 16, 2013, previously published on May 14, 2013 In the Federal Register of May 8, 2013, FDA announced a public meeting titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” The notice states that the focus of the meeting will be “FDA's interpretation of its regulations...
| | FOIA Delays Lead to Tongue Lashing by the Fourth Circuit
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article May 13, 2013, previously published on May 9, 2013 A recent Freedom of Information Act (“FOIA”) decision from the U.S. Court of Appeals for the Fourth Circuit sends a strong message to federal agencies that the statutory time limits for FOIA responses must be honored.
| | Labeling of GE Foods on the Horizon?
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 10, 2013, previously published on May 8, 2013 Senator Barbara Boxer (D-Calif.) and Representative Peter DeFazio (D-Ore.) recently introduced the Genetically Engineered Food Right-to-Know Act (S. 809 and H.R. 1699) that would direct FDA to require labeling to identify genetically engineered (“GE”) foods “so that consumers can...
| | Generic and Innovator Drugs: The Next Generation
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 8, 2013, previously published on May 7, 2013 Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Dr. Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun). I also remember the September 1987...
| | FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 6, 2013, previously published on May 5, 2013 By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York that FDA, within 30 days, make levonorgestrel-based...
| | False Friends: FDA’s “Gift” on NESINA - Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 6, 2013, previously published on May 2, 2013 Frau Rommelfanger’s seventh grade German class: that’s where we first learned to appreciate “false friends,” which are pairs of words or phrases in two languages that look or sound alike, but differ significantly in meaning. Never write the word “gift” on a...
| | Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article May 3, 2013, previously published on May 1, 2013 Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.
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