• where experts go to learn about FDA
  • Miscellaneous

    • HP&M Attorneys to Present Audioconference on Unannounced FDA RaidsSeptember 9th, 2009

      On September 10, 2009, Hyman, Phelps & McNamara’s John R. Fleder and William T. Koustas will speak at a Thompson Interactive audioconference on FDA’s use of criminal search warrants.  The audioconference, titled “Unannounced FDA Raids: Be Ready Before They Appear at Your Door,” will cover the …

    • We Need Your Help! Nominate FDA Law Blog for the ABA Blawg 100September 8th, 2009

      For the past couple of years the American Bar Association (“ABA”) has published a list of the top 100 legal “blawgs” in the blogosphere – The ABA Blawg 100!  The ABA is currently soliciting nominations for its 3rd annual list.  Although FDA Law Blog was …

    • Tobacco Manufacturers Challenge Constitutionality of Family Smoking Prevention and Tobacco Control ActSeptember 1st, 2009

      By David B. Clissold & Ricardo Carvajal – Five tobacco manufacturers including R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, and Commonwealth Brands, Inc. (the second, third, and fourth  largest tobacco manufacturers in the U.S., respectively), and a retailer of tobacco products have sued FDA in a …

    • Nanotech Update: FDA Enters Into MOU With Air Force Research Laboratory to Facilitate Sharing of Nanotoxicology InformationAugust 27th, 2009

      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 …

    • FDA Establishes Tobacco Products Scientific Advisory Committee and Requests Nominations for MembersAugust 26th, 2009

      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 …

    • HPM Attorney to Speak at Upcoming Conferences on Hatch-Waxman IssuesAugust 24th, 2009

      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 …

    • FDA Announces Launch of Center for Tobacco Products; HPM Attorneys to Present Webinar on the Family Smoking Prevention and Tobacco Control ActAugust 20th, 2009

      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 …

    • First Anniversary of the Consumer Product Safety Improvement Act of 2008August 14th, 2009

      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 Scott Hensley Back to the BlogosphereAugust 10th, 2009

      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 …

    • Anne Northrup to be Nominated as CPSC CommissionerJuly 31st, 2009

      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 …

    • FTC Extends Deadline for Red Flags RuleJuly 29th, 2009

      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, …

    • New CPSC Chairman is Sworn InJuly 10th, 2009

      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 …

    • FDA Law Blog is now on Twitter!July 8th, 2009

      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 …

    • August 1, 2009 – FTC’s New Identity Theft Rule Probably Requires You To ComplyJuly 1st, 2009

      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 …

    • Implementation of the Family Smoking Prevention and Tobacco Control Act: FDA Wants to Hear From YouJune 30th, 2009

      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 …