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General Practice. Securities, Litigation, Tax, Environmental, Labor & Employment, Banking, High Technology, Biotechnology, Real Estate, Transportation, Energy/Utilities, International, Bankruptcy, Copyright, Trademark, Patent and Intellectual Property Law, Health Care, Government Relations, Education, Estate Planning and Probate, White Collar Crime, Business, Corporate Finance, Land Use, Immigration, Trials and Appeals in all Courts.
Documents by Lawyers at this office | |
Charitable Giving Initiative Under Consideration by Massachusetts LegislatureKevin C. Conroy,Noah J. Kaufman,Sharon C. Lincoln, February 14, 2012
A proposed law under consideration in Massachusetts may make it easier for Massachusetts residents to financially support their favorite charity. For charitable organizations that have seen declining levels of donations over the past few years, the proposed law might create a new avenue through...
FDA Releases Long-Awaited Draft Guidances on Biosimilar Product DevelopmentBarbara A. Fiacco,James M. Flaherty,Paul T. Kim,Donald R. Ware, February 13, 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Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars.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...
FDA’s Draft Guidance on Scientific Considerations in Demonstrating BiosimilarityBarbara A. Fiacco,James M. Flaherty,Paul T. Kim,Donald R. Ware, February 13, 2012
Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the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...