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Hyman, Phelps & McNamara, P.C. Document Search Results (253) Show: results per page Sort by:  | FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary Judgment
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 7, 2013, previously published on January 2, 2013 Last week in a post-Christmas decision, Judge John D. Bates of the U.S. District Court for the District of Columbia granted both FDA’s and Intervenor-Defendant Ranbaxy Laboratories Limited’s (“Ranbaxy’s”) Motions for Summary Judgment and denied Mylan Laboratories...
| | The Prosecution of Gary D. Osborn—An Old School “Park” Prosecution?
John R. Fleder; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 2, 2013, previously published on January 1, 2013 We have extensively written about the “Park Doctrine”. In United States v. Park, 421 U.S. 658 (1975), the Supreme Court authorized the government to criminally prosecute individuals for violations of the FDCA even if a corporate official is unaware of the violation, if the individual...
| | DEA Proposes Disposal Regulations Addressing the “Medicine Cabinet” Syndrome
Larry K. Houck; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 2, 2013, previously published on December 31, 2012 The Drug Enforcement Administration (“DEA”) published its long awaited notice of proposed rulemaking to implement the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). 77 Fed. Reg. 75,784 (Dec. 21, 2012). Interested persons should submit electronic...
| | Are Food Allergen Thresholds on the (Far) Horizon?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 28, 2012, previously published on December 27, 2012 Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.” Undeclared major food allergens continue to be one of the two...
| | Your Dog as a Medical Device?
Jeffrey N. Gibbs, Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 27, 2012, previously published on December 26, 2012 A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions. For example, in the United Kingdom an organization called “Medical Detection Dogs”...
| | When is Yogurt Not Yogurt? Judge Lets FDA Decide
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 26, 2012, previously published on December 25, 2012 District Judge Susan Nelson of the District of Minnesota recently concluded that FDA is best qualified and has been authorized by Congress to decide whether Milk Protein Concentrate (“MPC”) is a “proper, permitted ingredient in yogurt.”
| | DEA Proposes Controlling Lorcaserin in Schedule IV
Larry K. Houck; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 26, 2012, previously published on December 20, 2012 The Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking in the December 19th Federal Register (77 Fed. Reg. 75,075 (Dec. 19, 2012)) to place lorcaserin into schedule IV of the federal Controlled Substances Act (“CSA”). Interested persons must...
| | Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 21, 2012, previously published on December 19, 2012 The Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) share some common ground. All three of the trade groups oppose a Safe Drug Disposal Ordinance...
| | FDA Releases Draft Guidance on Enrichment Strategies for Clinical Trials
Alexander J. Varond; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 20, 2012, previously published on December 18, 2012 On December 14, FDA released a draft guidance document entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Enrichment Guidance”). The thirty-nine-page document was more than six years in the making and aims to...
| | In a Milestone for Regulation of Imported Foods, New Zealand and U.S. Food Safety Systems are Deemed Comparable
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 19, 2012, previously published on December 18, 2012 FDA announced that it executed a Food Safety Systems Recognition Arrangement ("RA") with its counterpart in New Zealand, the Ministry for Primary Indsutries ("PMI"). The RA is the culmination of an assessment that began in 2010 and included both paper and on-site reviews. Based...
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