Draft guidance outlines recommendations for formal meetings between FDA and biosimilar sponsors and applicants *

USA - May 6 2013
The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for…

Co-authors: James S. Cohen, Michael W. Ryan.

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Supreme Court hears oral argument in pay-for-delay patent settlement antitrust case *

USA - March 26 2013
The Supreme Court's ruling in Federal Trade Commission v. Actavis, Inc., will almost certainly have major implications for the viability of Federal…

Co-authors: Jeffrey W. Brennan.

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Federal court vacates conviction for truthful off-label promotion of FDA-approved drug *

USA - December 11 2012
In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit ruled on December 3, 2012, that the Federal Food, Drug and Cosmetic Act’s misbranding provisions do not prohibit or criminalize truthful speech that promotes the lawful, off-label use of FDA-approved prescription drugs.

Co-authors: James S. Cohen, Jiayan Chen.

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New flexibility for pharmaceutical and medical device companies in Massachusetts, but at a price *

USA - August 1 2012
In July 2012 Massachusetts amended its Gift Ban Law and its Anti-Kickback Statute, both of which are among the most restrictive state laws of their kind.

Co-authors: James S. Cohen, Jennifer S. Geetter, Joan Polacheck, Susan S. Lee.

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CMS to extend timetable for implementation of the Physician Payments Sunshine Act *

USA - May 7 2012
On December 19, 2011, the U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule to implement the Physician Payments Sunshine Act, which was included as part of the Patient Protection and Affordable Care Act of 2010.

Co-authors: Jennifer S. Geetter, Joan Polacheck, Bernadette M. Broccolo.

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