Colleen Heisey

Member
Washington,  DC  U.S.A.
Phone202-879-3939

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Experience & Credentials
 

Practice Areas

  • Health Care
     
    University Lycoming College, B.S., 1999; Johns Hopkins University School of Public Health, M.P.H., 2006
     
    Law SchoolGeorge Washington University, J.D., 2002
     
    Admitted2002, California; 2003, District of Columbia
     
    ISLN917075016
     

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    FDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
    Laurie A. Clarke,Colleen Heisey,Mark Mansour,Christopher M. Mikson,Emily K. Strunk, July 22, 2014
    According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As...

    FDA Continues to Bolster Regulation of Compounding Pharmacies
    Laurie A. Clarke,Colleen Heisey,Mark Mansour,Christopher M. Mikson,Emily K. Strunk, July 22, 2014
    Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

    Payers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
    Laurie A. Clarke,Colleen Heisey,Mark Mansour,Christopher M. Mikson,Emily K. Strunk, July 22, 2014
    Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

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    Office Information

    Colleen Heisey

    51 Louisiana Avenue, N.W.
    WashingtonDC 20001-2113




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