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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The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for…
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.
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.
USA - July 11 2012
After months of negotiations, on July 9, 2012, President Obama signed bipartisan legislation that authorizes the U.S. Food and Drug Administration (FDA) to assess user fees to support the agency’s review of marketing applications for drugs, biologics and medical devices.
USA - June 20 2012
The Federal Communications Commission recently adopted rules that will enable the growth of Medical Body Area Networks, low-power wideband networks that transmit a variety of patient data recorded through patient-worn sensors to a hub device.
