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Search Results (2471) Documents on pharmaceuticals Show: results per page Sort by:  | The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2012, previously published on February 9, 2012 In music, “coda” is a term used primarily to designate a passage that brings a piece (or a movement, which may be part of a symphony - an extended musical composition) to an end - the “fine.” A coda can be as simple as a few measures, or as complex as an entire section. ...
| | “Soon” Has Finally Come; FDA Issues Three Highly Anticipated Biosimilars Draft Guidances
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 Within moments of FDA’s (Dr. Janet Woodcock) announcement during the February 9th House Energy and Commerce hearing on generic drug and biosimilar user fees that the Agency would issue draft guidance on biosimilar product development later in the day, Twitter was, well . . . . all atwitter...
|  | FDA Releases Long-Awaited Draft Guidelines on Biosimilars
Paul A. Calvo, Timothy J. Shea; Sterne, Kessler, Goldstein & Fox P.L.L.C.;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 On Thursday, the U.S. Food and Drug Administration issued the Agency’s first set of draft guidance documents outlining the framework for how it will evaluate applications for regulatory approval of biosimilar products. The long-awaited guidances provide the first detailed comments from FDA on...
| | CMS Issues Proposed Rule to Implement Drug Pricing and Rebate Provisions of the Affordable Care Act
Shelton Abramson, Stefanie A. Doebler, Demetrios L. Kouzoukas, Anna D. Kraus; Covington & Burling LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 On February 2, 2012, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would implement sections of the Affordable Care Act (ACA) and make other revisions to the Medicaid Drug Rebate Program (MDRP). The proposed rule addresses a broad range of issues related to...
| | DC District Court Grants FDA Summary Judgment in Generic LOVENOX Dispute
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 10, 2012, previously published on February 7, 2012 On February 7, 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia issued her decision in the long-running dispute concerning FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 077857 for a generic version of...
| | Supreme Court Rejects Case from First Circuit on Junk Science
Suna Lee, Carolyn Flanagan O'Connor; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article February 10, 2012, previously published on February 9, 2012 On January 9, 2012, the U.S. Supreme Court in U.S. Steel Corp., et al. v. Brian Milward, et al., No. 11-316 rejected defendants’ petition for review of a decision by the First Circuit that threatens to open the door, at least within that circuit, to scientifically unreliable expert testimony...
| | FDA Finalizes Guidance on Prescription Drug Product Name Placement, Size and Prominence in Advertising and Promotional Labeling
Heather D. Banuelos, Gary C. Messplay; Hunton & Williams LLP;
Legal Alert/Article February 10, 2012, previously published on February 2012 In late January, the U.S. Food and Drug Administration (“FDA”) announced a final guidance document entitled “Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.” The guidance finalizes draft guidance published in 1999...
| | The 2012 Rx&D Code Of Ethical Practices
Louis Clément, Bonnie Freedman, Manon Gauthier, P. Jeffrey S. Graham; Borden Ladner Gervais LLP;
Legal Alert/Article February 8, 2012, previously published on February 2012 Effective March 31, 2012, the members of Canada’s Research-Based Pharmaceutical Companies (“Rx&D”) will be subject to a new Code of Ethical Practices (the “New Code”).
| | Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in Shortage
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 7, 2012, previously published on February 3, 2012 Earlier this week, Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced H.R.3839, the “Drug Shortage Prevention Act,” which, according to its sponsors, is intended to bring “more efficiency to the manufacturing and distribution processes” and to require...
| | GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged Innovation
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 7, 2012, previously published on February 1, 2012 A new report released by the Government Accountability Office (“GAO”), titled “Antibiotics: FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information,” says that since the September 27, 2007 enactment of the FDA Amendments Act (“FDAAA”) FDA...
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