By Ricardo Carvajal – In an apparent effort to leverage against the scientific resources of other federal agencies, FDA’s National Center for Toxicological Research (“NCTR”) has entered into a Memorandum of Understanding (“MOU”) that provides for the sharing of nanotoxicology information with the Air Force …
By David B. Clissold & Ricardo Carvajal – As required by the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”), FDA has established the Tobacco Products Scientific Advisory Committee (“TPSAC”) and is requesting nominations for voting and non-voting members. The Commissioner will select the …
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at two upcoming conferences on various Hatch-Waxman issues. The first conference is the American Conference Institute’s (“ACI’s”) popular Maximizing Pharmaceutical Patent Life Cycles (10th Anniversary Edition), and is scheduled for October 6-10, 2009 at …
As directed by the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”), FDA has created its new Center for Tobacco Products (“CTP”). CTP will be led by Dr. Lawrence Deyton of the George Washington University School of Medicine and Health Sciences. FDA’s press release …
By Michelle L. Butler – Today, August 14, 2009, is the anniversary of the passage of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), which means that a number of new requirements will go into effect. It also means that the Consumer Product Safety …
FDA Law Blog welcomes back to the blogosphere our friend Scott Hensley, formerly of the Wall Street Journal (where he was the founding editor and a regular contributor to the paper’s Health Blog). Scott will be blogging at the National Public Radio Health Blog and …
Yesterday, President Obama announced that he intends to nominate Anne Northrup as a Commissioner of the Consumer Product Safety Commission. Anne Northrup was a Congresswoman from Kentucky from 1997-2006. As we previously reported, earlier this month, Inez Moore Tenenbaum was sworn in as the ninth …
By William T. Koustas – Today, the FTC announced that it is delaying enforcement of the controversial Red Flags Rule (“the Rule”) until November 1, 2009. The FTC press release states that it is extending the August 1, 2009 deadline, previously discussed in this blog, …
The Consumer Products Safety Commission (“CPSC”) yesterday announced that former South Carolina State Superintendent of Education Inez Moore Tenenbaum has been sworn in as the ninth CPSC Chairman. We previously reported on her nomination and President Obama’s plans to expand the CPSC from the current …
Sigh. We've been dragged (kicking and screaming) into the 21st Century. So, we've put down our quill pens and are now twittering at www.twitter.com/fdalawblog. Many of our "tweets" will link to the blog, but we will also be putting up other FDA-related news and updates …
By William T. Koustas & John R. Fleder – FDA-regulated businesses are certainly closely regulated by FDA and other federal agencies. However, one area that many of these businesses erroneously believe does not affect them is the federal laws and regulations that apply to identity theft. The …
By David B. Clissold & Ricardo Carvajal – In an unusually open-ended request, FDA is asking “all interested parties to provide information and share views” on FDA’s implementation of the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), which was signed into law on …
FDA recently launch a redesigned website that is aimed at improving the “look and feel” of all FDA websites. According to the Agency: The new site organization is intended to allow you to find information more quickly: Information is categorized by topic for easier retrieval, with …
By Michelle L. Butler – On May 20, 2009, the President signed the Fraud Enforcement and Recovery Act of 2009 (“FERA”), which is purported to be aimed at improving enforcement of fraud, including fraud related to Federal assistance and relief programs. Among other things, this …
By JP Ellison – We previously reported on the President’s FOIA Memorandum and the Attorney General’s FOIA Guidelines encouraging discretionary disclosure. Today, the D.C. Circuit handed the Administration a FOIA win that shows the importance of such discretionary disclosures, given FOIA’s exemptions. In CREW v. …
