On June 29, 2007, the U.S. District Court for the District of Columbia, in Mylan v. Leavitt, issued a memorandum opinion denying Mylan’s Emergency Motion for a Temporary Restraining Order that asked the court to order FDA to relist Pfizer’s U.S. Patent No. 4,879,303 covering …
On June 25, 2007, the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant to the Premarket Approval (“PMA”) process. In 1996, the Supreme Court held in …
A colleague of your trusted bloggers spoke with counsel for the Nevada Board of Pharmacy (“BOP”) and reports the following about the new law in our post from yesterday: A draft regulation will be posted on the BOP website next week. BOP welcomes comments on the …
On June 14, 2007, Nevada Governor Jim Gibbons signed into law Assembly Bill 128, which is similar to the drug marketing compliance law that went into effect in California in July 2005. Nevada’s new law, which goes into effect on October 1, 2007, requires a …
At long last, 13 years after the Dietary Supplement Health and Education Act (“DSHEA”) of 1994 authorized their creation, and four years after publication of the proposed rule, FDA issued its final current Good Manufacturing Practice (cGMPs) regulations for dietary supplements on June 25, 2007. …
On May 14, 2007, Representatives John Dingell (D-MI), Henry Waxman (D-CA), and Bart Stupak (D-MI) sent a letter to the Government Accountability Office (“GAO”) requesting that the office update its July 2000 report on the safety of dietary supplements and functional foods. Congress’ increased scrutiny …
