Search Results (184)
Documents on Antitrust & Trade Regulation, Manufacturing
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|Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement|
John T. Bentivoglio, Jennifer L. Bragg, Maya P. Florence, Michael K. Loucks, Gregory M. Luce; Skadden, Arps, Slate, Meagher & Flom LLP;
May 17, 2013, previously published on May 15, 2013On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a global settlement pursuant to which Ranbaxy will pay a total of $500 million to resolve criminal and...
|Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between "Traditional Compounders" and "Compounding Manufacturers"|
Duane Morris LLP;
May 2, 2013, previously published on April 29, 2013In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on Health, Education, Labor & Pensions ("HELP") released...
|Rare Proposition 65 Trial Could Spark Robust Appellate Litigation|
Crowell Moring LLP;
April 23, 2013, previously published on April 19, 2013Trials in Proposition 65 cases are extremely rare—only 9 out of 3000 have actually gone to trial since the voter initiative went into effect in 1986. Currently, however, a private Prop 65 enforcer, The Environmental Law Foundation (ELF), is engaged in a bench trial against 16 baby food...
|Stengel v. Medtronic En Banc Decision Narrows Preemption Doctrine to the Detriment of Medical Device Manufacturers|
Noushan Noureddini; Morris Polich & Purdy LLP;
January 28, 2013, previously published on January 22, 2013A recent Ninth Circuit Court of Appeals en banc decision marks a less than desirable shift in preemption law for medical device manufacturers. In Stengel v. Medtronic Inc. (Jan. 10, 2013) --- F.3d --- (2013 WL 106144), the Ninth Circuit granted rehearing en banc and unanimously reversed the...
|DC District Court Sews Up Generic VANCOCIN Litigation; Decision Merely Refines and Adds New Details to Previous Preliminary Injunction Decision|
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
January 17, 2013, previously published on January 14, 2013In a decision handed down last week by Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia, the court may have finally put an end to ViroPharma Inc.’s (“ViroPharma’s”) litigation over FDA’s approval of generic versions of the...
|FDA Issues Sweeping New Regulations Targeting Food Manufacturers, Processors, Packers, Holders, and Farms|
John B. Brew, John H. Fuson, Michael L. Kuppersmith; Crowell & Moring LLP;
January 11, 2013, previously published on January 8, 2013On January 4, 2013, the United States Food and Drug Administration (FDA) proposed two new rules implementing key provisions of the 2011 Food Safety Modernization Act (FSMA). The first targets foodborne illnesses generally, while the second proposes specific safety standards for the production and...
|FDA Announces Publication of Two Proposed Rules Implementing the Food Safety Modernization Act|
Nathan A. Beaver, Michael D. Flanagan; Foley & Lardner LLP;
January 9, 2013, previously published on January 7, 2013On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011. The two proposed rules, entitled Current Good Manufacturing Practice and...
|Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance|
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
December 21, 2012, previously published on December 19, 2012The 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...
|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.;
December 19, 2012, previously published on December 18, 2012FDA 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...
|The First Amendment Trumps the FDA - For Now|
Charles E. "Chuck" James; Williams Mullen;
December 17, 2012, previously published on December 12, 2012On December 3, 2012, the U.S. Court of Appeals for the Second Circuit issued a 2-1 decision vacating Alfred Caronia’s misdemeanor conviction for off-label promotion of Xylem in violation of the Food, Drug and Cosmetic Act (“FDCA”) and 21 U.S.C. §§ 331(a) and (a)(1). As...