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Hyman, Phelps & McNamara, P.C. Document Search Results (255) Show: results per page Sort by:  | Insight into FDA’s Implementation of FDASIA for Devices
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 27, 2012, previously published on September 25, 2012 On Thursday, September 20, the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”) co-sponsored a program titled “Unwrapping FDA’s UFA Package: What’s Inside the Statute - What’s Next?” The program discussed many...
| | FDA Issues Draft Compliance Guide on Pet Food Intended to Diagnose, Cure, Mitigate, Treat or Prevent Disease, Including Obesity
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 27, 2012, previously published on September 20, 2012 Earlier this month, FDA announced the publication of a draft level 1 Compliance Policy Guide (“CPG”) titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.”
| | Is it a Drug or Device? Court Requires FDA to Explain Itself
Jennifer M. Thomas, Anne K. Walsh; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 27, 2012, previously published on September 26, 2012 Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a drug. The original...
| | Suit Targeting Benecol Dismissed on Preemption Grounds
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 27, 2012, previously published on September 24, 2012 A federal district court dismissed a class action that took issue with a number of allegedly false and misleading claims made on the label of Benecol, a butter/margarine alternative. The claims at issue include “each serving contains .85g of plant stanol esters,” “proven to...
| | Legislative Fix Would Allow FDA to Collect GDUFA User Fees
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 21, 2012, previously published on September 19, 2012 Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate). A draft of the FDA User Fee Corrections Act of...
| | The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted
James P. Ellison, Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 21, 2012, previously published on September 18, 2012 The U.S. Solicitor General filed a brief last week urging the U.S. Supreme Court not to grant a Petition for Writ of Certiorari filed earlier this year by a group of ear candle advocates after the U.S. Court of Appeals for the District of Columbia Circuit affirmed in a January 2012 decision the...
| | Patent Settlement Agreements: The Next Barrage
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 19, 2012, previously published on September 17, 2012 In our recent post, “Hot Ticket Item - Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term - we don’t)....
| | In Florida, Watch How You Use “Honey”
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 18, 2012, previously published on September 17, 2012 A federal court has ruled that the express preemption provisions added to the Federal Food, Drug, and Cosmetic Act (“the Act”) by the Nutrition Labeling and Education Act (“NLEA”) do not preempt Florida’s standard of identity for honey. Plaintiffs in the case, Guerrero...
| | Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 17, 2012, previously published on September 12, 2012 While Congress and The White House debate whether user fees paid pursuant to various UFAs - User Fee Acts - will be sequestered under the terms of the Budget Control Act, FDA continues to move forward with planning for Fiscal Year (“FY”) 2013. In a notice that will be published in the...
| | FTC Settlement with Medifast: Weight Loss and Maintenance Claims Must be Supported by One (Not Two) Well-controlled Study
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article September 17, 2012, previously published on September 13, 2012 Earlier this week, the Federal Trade Commission (“FTC”) announced the settlement of a $3.7 million civil penalty case against Jason Pharmaceuticals (“Jason”), a subsidiary of Medifast Inc., for allegedly violating a 1992 FTC Order regarding weight loss claims. According to...
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