It’s that time of year again when we ask our loyal FDA Law Blog readers for just a few minutes of their time. You got it: it’s the best legal blog nomination season! And this year, there are two contests for which we’re seeking your …
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It’s that time of year again when we ask our loyal FDA Law Blog readers for just a few minutes of their time. You got it: it’s the best legal blog nomination season! And this year, there are two contests for which we’re seeking your …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that five of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2015 Washington DC Super Lawyers Magazine. Super Lawyers is a rating service of outstanding lawyers from more …
The American Conference Institute (“ACI”) will hold its 26th FDA Boot Camp conference in Boston, Massachusetts from September 30 to October 1, 2015. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will co-chair the event with …
By Ricardo Carvajal & JP Ellison - On March 9, the Supreme Court handed down a decision in Perez v. Mortgage Bankers Association that does away with what we’ll refer to in this posting as the Paralyzed Veterans doctrine, after an appellate court decision by that same name. The Paralyzed Veterans doctrine …
Attached here is the obituary of Frank Hurley, as issued by his company RRD International. Frank was a Co-Founder of RRD as well as its Chairman and Chief Scientific Officer. The obituary’s rich detail correctly describes his professional reputation as the premier innovator in his …
By Kurt R. Karst – The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”). Although Dr. Uhl has manned the helm at OGD …
While we were busy preparing for our Thanksgiving holiday last week, we received the email we had been hoping for: a congratulatory email from the editors of the American Bar Association (“ABA”) Journal announcing that Hyman, Phelps & McNamara, P.C.’s FDA Law Blog was selected …
Hyman, Phelps & McNamara, P.C. has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers for …
The American Conference Institute’s popular FDA Boot Camp, now in its 23rd iteration, is slated to take place at the Omni Parker House Boston in Boston, MA from Thursday, September 18 to Friday, September 19, 2014. The conference is billed as the premier event to …
It’s July, and that means the American Bar Association (“ABA”) has initiated the annual process for selecting the top legal blogs (or “blawgs”) in the blogosphere. The 8th iteration of the list will be revelaed later this year when the ABA announces the “Blawg 100” …
By Jeffrey N. Wasserstein – We have previously noted that FDA has increasingly regulated through issuance of guidance documents – rather than through notice-and-comment rulemaking as required by the Administrative Procedure Act. The U.S. Senate Committee on Health, Education, Labor, and Pensions (the Senate HELP Committee) …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that six of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2014 Washington DC Super Lawyers Magazine. Super Lawyers is a rating service of outstanding lawyers from more …
Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month. Well, it’s here …
(In our best Don LaFontaine voice) IN A WORLD where food and drug attorneys and regulatory professionals are all work and no play, there’s something coming to relieve the monotony and to spice up your work life. That’s right, after a very, very long hiatus, our “Lighter Side …
The Food and Drug Law Institute (“FDLI”) recently announced that President and Chief Executive Officer Susan C. Winckler will step down from that position effective May 23, 2014. Ms Winckler, a pharmacist and attorney, was named to the position in November 2009. She previously served …