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FDA Law Blog

Hyman, Phelps & McNamara, P.C.
FDA Law Blog  
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Court Issues Opinion in Red Flags Rule Lawyers Case That May Have Broader Applicability to Other Businesses

Dec 4, 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...

FDA Proposes Timetable for Review of Modified Risk Tobacco Products

Dec 3, 2009
By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).  FDCA section 911(a) prohibits the introduction...

WLF Supports Allergan's Challenge to FDA's Policies on Off-Label Speech

Dec 2, 2009
By Carrie S. Martin –       On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment challenge to FDA’s ban on...

You Like Us, You Really Like Us!

Dec 1, 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...

Settlement in False Claims Act Suit is no bar to suing the Consultant

Dec 1, 2009
By Jeffrey N. Wasserstein – We missed this interesting decision in the run-up to Thanksgiving.  Now that we’ve recovered from our tryptophan-induced sleepiness, we found this case to be of particular interest.  We previously blogged on the Cell...


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