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Patent Law

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FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

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By Donald Zuhn -- Last week, the congressional daily The Hill reported on a draft notice from the Food and Drug Administration (FDA) that was being circulated among healthcare lobbyists on Capitol Hill. The notice, which the agency has yet to publish in the Federal Register, concerns public hearings and a request for comments on the approval pathway for biosimilar biological products that was created last March when President Obama signed the Patient Protection and Affordable Care Act (PPACA) into law. According to the draft notice, the FDA is planning to hold public hearings on Tuesday, November 2 and Wednesday,...

Full post as published by Patent Docs on September 30, 2010 (boomark / email).

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