Recent posts on www.lifescienceslegalupdate.com include:
"Commentary: FDA's New Good Reprint Practice Rule". The Food and Drug Administration's new Good Reprint Practice ("GRP") Guidance went into effect January 2009. The GRP Guidance establishes criteria that FDA will now use to determine whether the distribution of medical or scientific reprints and reference texts about off-label uses of a drug or device would constitute impermissible promotional activity under the Food, Drug and Cosmetic Act.
...and "Dept. of Bad Ideas: Criminalization of Product Liability" regarding the 2006 proposal by Senator Arlen Specter (R.-PA) to criminalize aspects of product liability law. https://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/dept-of-bad-ideas-criminalization-of-product-liability/… Continue Reading
This post was also written by Areta L. Kupchyk, and James M. Wood. On February 15, 2008, a year-and-a-half after the sunset of the statute (Section 401 of the Food and Drug Administration Modernization Act) intended to permit the dissemination of medical literature about unapproved uses of drugs and medical devices, the Food and Drug … Continue Reading