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    • Hyman, Phelps & McNamara, P.C. Welcomes New Director, Karla PalmerAugust 12th, 2010

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Karla L. Palmer will join the Firm as a Director on Monday. Karla brings significant experience in civil and administrative litigation matters. At Hyman, Phelps & McNamara, she will focus on a wide range of …

    • HP&M Attorney Elected to USP Expert CommitteeJuly 14th, 2010

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Diane B. McColl has been elected to  the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle.  The committee develops new monographs and revises …

    • HP&M Attorney Elected to USP Board of TrusteesJune 29th, 2010

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Frank J. Sasinowski has been elected by the the U.S. Pharmacopeial Convention (“USP”) as an At-Large Trustee of the USP Board of Trustees for the 2010-2015 cycle.  The Board of Trustees will guide the activities …

    • FTC Delays Enforcement of the Red Flags Rule…AgainMay 28th, 2010

      By William T. Koustas – As we have previously reported (here, here, and here), the FTC has delayed enforcement of its Red Flags Rule (“the Rule”) several times since its original effective date of November 1, 2008.  Now, some in Congress have requested that the …

    • FDA’s Regulation of Nanotech: a Change in the Wind?May 19th, 2010

      By Ricardo Carvajal – FDA’s approach to regulation of nanotechnology has remained essentially unchanged since the issuance of the agency’s Nanotechnology Task Force Report in 2007.  In that report, which was endorsed by then-Commissioner von Eschenbach, FDA declined to adopt a formal definition of nanotechnology, …

    • FDA Law Blog Turns 3!March 5th, 2010

      Yep, it’s been three years since we started FDA Law Blog.  And that means it’s time again to take a minute from blogging on FDA issues to pat ourselves on the back.  It’s been a banner year for us.  We recently topped 800 posts (almost …

    • What are the Benefits and Risks of Having a Lawyer Testify About Legal Advice Previously Provided to a Client about FDA Matters?January 31st, 2010

      For heavily-regulated companies, such as those regulated by the Food and Drug Administration, it is common for companies to seek advice from in-house and outside counsel regarding whether proposed conduct would violate the law. It has become increasingly popular for federal prosecutors to target the …

    • Senators Pryor and Cardin introduce the Nanotechnology Safety Act of 2010January 24th, 2010

      By Ricardo Carvajal – According to a press release issued by Senator Mark Pryor's office, Senator Pryor (D-AR) has teamed up with Senator Benjamin Cardin (D-MD) to introduce the Nanotechnology Safety Act of 2010.  The bill, introduced on January 21, 2010 as S. 2942, is …

    • In Memoriam – Stephen H. McNamaraDecember 28th, 2009

      Our colleague and friend, Stephen H. McNamara passed away on December 28, 2009 of complications from cancer at the age of 66.  Steve is survived by Caroline, his wife of 43 years, and his children, Matthew (Veronica) McNamara, and Deborah  (Nicholas) Hutchins and six grandchildren.  Steve was …

    • CPSC Votes to Lift the Stay of Testing and Certification Requirements for Certain Products and Extend the Stay for OthersDecember 21st, 2009

      By Michelle L. Butler – The Consumer Product Safety Commission (“CPSC” or “Commission”) has now voted to lift the stay of the testing and certification requirements for certain products and extend the stay for others.  The Commission issued a press release last Friday regarding the decision, …

    • Consumer Product Safety Improvement Act – Stay of Enforcement of Certain Testing and Certification Requirements Likely to be LiftedDecember 17th, 2009

      By Michelle L. Butler – On December 16, 2009, the Consumer Product Safety Commission (“CPSC” or “Commission”) posted on its website a draft Federal Register notice that would announce the Commission’s decision to revise the terms of its stay of enforcement of certain testing and …

    • Court Issues Opinion in Red Flags Rule Lawyers Case That May Have Broader Applicability to Other BusinessesDecember 4th, 2009

      By William T. Koustas – We previously reported that the United States District Court for the District of Columbia ruled in favor of the American Bar Association and prevented the Federal Trade Commission ("FTC") from enforcing its Red Flags Rule (“the Rule”) on attorneys.  On …

    • You Like Us, You Really Like Us!December 1st, 2009

      Thanks to our faithful readers, we made the list for the Third Annual ABA Journal Blawg 100.  One of our readers, an FDA official, said that “there is no one within the agency that does what this blog provides.”  We are humbled by this honor and hope …

    • Hyman, Phelps & McNamara, P.C. Announces Two New DirectorsNovember 17th, 2009

      Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation.  Mr. …

    • CPSC Holds Public Hearing on Draft Guidance Document on CPSIA Testing and Certification RequirementsNovember 10th, 2009

      By Michelle L. Butler – Yesterday, the Consumer Product Safety Commission (“CPSC” or “Commission”) held a public hearing on the draft guidance document proposed by the Commission staff regarding “Testing and Certification Requirements Under the Consumer Product Safety Improvement Act of 2008.”   The hearing was conducted …