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Search Results (2082) Documents on biotech life sciences Show: results per page Sort by:  | FDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009
W. Blake Coblentz, Lee Crews, L. Norwood "Woody" Jameson, Vicki G. Norton, Siegfried J.W. Ruppert; Duane Morris LLP;
Legal Alert/Article February 15, 2012, previously published on February 13, 2012 On February 9, 2012, the U.S. Food and Drug Administration (FDA) issued eagerly anticipated draft guidance documents on biosimilar product development in three installments, collectively the "Biosimilar Draft Guidances":
| | MDR Reporting - FDA Appears to Disavow The Two Year Presumption
Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 15, 2012, previously published on February 14, 2012 This post is the second in an occasional series that will examine significant or interesting warning letters involving medical device companies.
|  | FDA Issues Highly Anticipated Draft Guidance on Biosimilars
Andrea C. Hutchison, Joseph A. Mahoney; Mayer Brown LLP;
Legal Alert/Article February 14, 2012, previously published on February 10, 2012 On February 9, 2012, the US Food and Drug Administration (FDA) issued three draft guidance documents regarding biosimilars (a/k/a follow-on biologics). These documents reflect the agency’s attempt to assist applicants seeking approval of a proposed biologic product under the abbreviated...
| | Biosimilars: Draft Guidance Documents Issued by FDA
Kimberly Weinreich, Jeffrey A. Wolfson; Haynes and Boone, LLP;
Legal Alert/Article February 14, 2012, previously published on February 14, 2012 The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010....
| | FDA Releases Long-Awaited Draft Guidances on Biosimilar Product Development
Barbara A. Fiacco, James M. Flaherty, Paul T. Kim, Donald R. Ware; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 9, 2012 Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars. Biosimilar products are biological products shown to be highly similar (biosimilar) to biological products previously approved by FDA (known as...
| | “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’s Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity
Barbara A. Fiacco, James M. Flaherty, Paul T. Kim, Donald R. Ware; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI...
| | Reps. Rogers and Markey Introduce Bill to Implement Withdrawn Pediatric Medical Device Rule
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 On Wednesday, February 8, Representatives Mike Rogers (R-MI) and Ed Markey (D-MA) introduced H.R. 3975, The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012. The bill would put into effect a rule previously withdrawn by FDA regarding the inclusion of pediatric...
| | France - A Revolution for the Medical Devices Industry
François-Régis Babinet, Genevieve Michaux; Covington & Burling LLP;
Legal Alert/Article February 13, 2012, previously published on February 13, 2012 French Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the ‘New Law’) will have a...
| | 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”).
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