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Hyman, Phelps & McNamara, P.C. Document Search Results (256) Show: results per page Sort by:  | Actelion Seeks Judgment on the Pleadings in Lawsuit Over Restricted Distribution and Biostudy Product Availability
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 28, 2013, previously published on January 23, 2013 Last week, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) filed what might be the company’s last motion in its preemptive lawsuit filed last September in the U.S. District Court for the District of New Jersey seeking declaratory relief...
| | FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for “Convenience Kits” Defined
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 28, 2013, previously published on January 24, 2013 The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. 78 Fed. Reg. 4307 (Jan. 22, 2013). This rule finalizes a proposed rule issued on September 23, 2009. The new rule, which appears in a newly added section to Title 21,...
| | FTC Hammers POM Wonderful: Now On to the World Series
John R. Fleder, Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 18, 2013, previously published on January 17, 2013 On January 16th, the Federal Trade Commission ("FTC") issued the long-anticipated Decision and Final Order in the FTC’s administrative case filed in 2010 against POM Wonderful LLC, Roll Global LLC, Stewart A. Resnick, Lynda Rae Resnick, and Matthew Tupper (collectively...
| | 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.;
Legal Alert/Article January 17, 2013, previously published on January 14, 2013 In 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 Sets GDUFA Fiscal Year 2013 Facility User Fee Rates; Fewer Facilities Result in Higher Rates
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 17, 2013, previously published on January 16, 2013 In a notice that will be published in the January 17th Federal Register, FDA announces the establishment of Fiscal Year 2013 (“FY2013”) user fee rates established pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) for both Active Pharmaceutical Ingredient...
| | FDA Considering Alternative Approval Pathway
Alexander J. Varond; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 17, 2013, previously published on January 15, 2013 FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical need. The new pathway would be used to approve...
| | Patient Power in Orphan Drugs
William T. Koustas, Frank J. Sasinowski; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 15, 2013, previously published on January 13, 2013 FDASIA/PDUFA V elevates the role of patients in developing orphan therapies. It mandates that FDA implement ways to bring patients' views into drug development and FDA’s regulatory review. This is appropriate as it is often these patients that push development of orphan drugs forward.
| | New FDA Draft Guidance “Abuse-Deterrent Opioids—Evaluation and Labeling” to Permit Abuse-Deterrent Labeling Claims
David B. Clissold; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 12, 2013, previously published on January 10, 2013 FDA has released a Draft Guidance for Industry, titled “Abuse-Deterrent Opioids—Evaluation and Labeling.” Since at least 2005, Congress has noted the need for FDA guidance governing the development and approval of abuse-deterrent drug products. See e.g., H.R. Rep. No. 109-102...
| | A Pre-MMA 180-Day Exclusivity Punt? What Gives?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 11, 2013, previously published on January 8, 2013 Although the number of cases involving 180-day exclusivity under the version of the FDC Act in effect before the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) is nearing an end, the pre-MMA statute, and the handling of it by FDA and the courts, never fails to...
| | When is 5-Year NCE Exclusivity Less Than 5 Years?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 11, 2013, previously published on January 9, 2013 Every once in a while we receive a series of similar questions from various quarters such that a critical mass has been reached justifying a blog post on the topic. This is one of those posts. And it has to do with the always hot - and particularly hot as of late - topic of 5-year New Chemical...
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