On July 6, 2007, the Centers for Medicare & Medicaid Services (“CMS”) posted on its website a pre-publication copy of a final rule with a comment period to implement the Medicaid Rebate Program. The regulation, which finalizes a proposal that was published in the Federal …
We previously reported on a proposed rule issued by the U.S. Department of Agriculture (“USDA”) to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205 to add 38 non-organic minor ingredients to the National List of Allowed and Prohibited Substances (“National …
Late Wednesday, the House of Representatives passed, by a vote of 403-16, H.R. 2900, “the Food and Drug Administration Amendments Act of 2007.” The Senate passed its version of omnibus FDA reform legislation in May 2007 — S. 1082, “the Food and Drug Administration Revitalization …
For the third time in as many years, FDA has been requested to provide an advisory opinion on the Agency’s policy for the submission of patents for Orange Book listing that cover drug delivery systems (e.g., metered-dose and dry powder inhalers, and transdermal patches) that …
In a July 3, 2007 filing with the Securities and Exchange Commission (“SEC”), Altus Pharmaceuticals Inc. announced that the company was notified by FDA’s Office of Orphan Products Development (“OOPD”) that the orphan drug designation granted in January 2002 to ALTU-135, also know as TheraCLEC, …
Positron Emission Tomography drugs, or PET drugs (not to be confused with drugs approved for companion animals), would be accorded more equitable user fee status under PDUFA IV if the Senate-passed version of the FDA Revitalization Act (“FDARA”) is signed into law. (A similar provision …
From the New York Times: “China executed its former top food and drug regulator today for taking bribes to approve untested medicine as Beijing scrambled to show that it is serious about improving the safety of Chinese products.”
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 …
The FDA announced it is postponing the annual registration of medical device establishments for 2008. The agency said this is a temporary action and it expects to resume annual registrations in October or November 2007. Establishments that are already registered for 2007 are valid until …
In a recently published white paper (registration required), Steven Richter, a former FDA official and President and Chief Scientific Officer of Microtest Labs, discusses the regulatory challenges facing combination products. The market for combination products is growing such that it is estimated to reach approximately …
