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FDA Releases Long-Awaited Draft Guidances on Biosimilar Product Development
Barbara 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Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars.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FDA’s Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity
Barbara 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Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the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...

HHS-DOL-Treasury Summary of Benefits and Coverage and Uniform Glossary Final Rule | Summary
Thomas Barker,Maia M. Larsson, February 13, 2012
Section 2715 of the Public Health Service Act (PHS Act), which was enacted as part of the Patient Protection and Affordable Care Act (also referred to as PPACA, the Affordable Care Act, or the ACA), requires health insurers and group health plans offering health care coverage to enrollees and...

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