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Hyman, Phelps & McNamara, P.C. Document Search Results (257) Show: results per page Sort by:  | FSIS Finalizes Rules Mandated by the 2008 Farm Bill
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 22, 2013, previously published on May 14, 2012 On May 8, 2012, the Food Safety and Inspection Service (“FSIS”) published three sets of regulations mandated by the 2008 Farm Bill: (1) regulations requiring that meat and poultry plants promptly (within 24 hrs) notify FSIS that a contaminated or misbranded product has been released...
| | FDA Speaks to Nanotech in Cosmetics, Foods, and Drugs
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 22, 2013, previously published on May 14, 2012 April was a busy month for nanotechnology at FDA. The agency issued two draft guidance documents worthy of close examination for those with an interest in the use of emerging technologies, including nanotechnology, in the cosmetic and food industries. Further, FDA denied a citizen petition asking...
| | While We’re Waiting on Bartlett, Some New Preemption Challenges to Consider
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 21, 2013, previously published on May 20, 2013 As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here), we thought we would whet the preemption appetite with two new...
| | 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...
| | 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 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...
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