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 …
By JP Ellison – On February 24, 2014, the U.S. Department of Justice announced a civil lawsuit and partial settlement arising out of alleged violations of statutes enforced by the Consumer Product Safety Commission (the “CPSC”). According to the press release, the complaint alleges that four California companies …
It’s been quite a month for Hyman, Phelps & McNamara, P.C. (“HP&M”)! First, the American Bar Association named the FDA Law Blog to the 2013 ABA Journal Blawg 100 (see here). Now there are three more honors to report! Earlier this week at the Food and …
We at the FDA Law Blog (and Hyman, Phelps & McNamara, P.C.) have a lot to be thankful for this Thanksgiving and holiday season. Thanks to our loyal readers, earlier this week, the American Bar Association (“ABA”) named our blog to the 2013 (and 7th …
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Larry K. Houck and Riëtte van Laack, PhD have been named Directors of the firm. Mr. Houck’s practice area encompasses controlled substances and regulated chemicals as well as state licensing and registration compliance issues. …
Hyman, Phelps & McNamara, P.C. is pleased to announce that James C. Shehan has joined the firm as Of Counsel. Previously, Mr. Shehan served for 19 years as Novo Nordisk Inc.’s General Counsel and Corporate Vice President of Legal, Government and Quality. His extensive experience …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served as a 2012-2013 White House Fellow assigned to the Secretary of Health and Human Services, …
By James R. Phelps – The Federal Register on July 10th published certain recommendations of the Administrative Conference of the United States, including one that independent regulatory agencies should prepare cost-benefit analyses for proposed and final regulations. This was very timely, coming just as I was …
It’s that time of year again when we at the FDA Law Blog ask our loyal readers to nominate us for the American Bar Association’s (“ABA’s”) Blawg 100. It’s a list of the top 100 legal blogs – or “blawgs” – in the blogosphere. With …
By William T. Koustas – The Federal Trade Commission (“FTC”) has just released a revised guidance on its Red Flags Rule (“the Rule”) based on the amended Rule issued late last year in an effort to comply with the Red Flag Program Clarification Act of …
Earlier this week, the National Organization for Rare Disorders (“NORD”) held its annual gala here in Washington, D.C. recognizing achievements and advances in the area of rare (orphan) diseases. Of course, this year is extra special; it’s the 30th anniversary of the enactment of the …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Joseph (“Jay”) W. Cormier, J.D., Ph.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Cormier served as a pharmacologist in the Animal Biotechnology Interdisciplinary Group in FDA’s Center for Veterinary …
By Kurt R. Karst – As food and drug attorneys, we rely on a certain level of FDA transparency to understand why FDA did what it did in a particular case, and to discern what that means for future Agency action (or inaction) in another …
By James R. Phelps – George Miller Burditt died on March 13, 2013 following a heart attack. He was 90 years of age. With his passing the food and drug bar lost one of its most distinguished members. People were drawn to George by his friendly, …
Many of us at Hyman, Phelps & McNamara, P.C. will miss a cherished former colleague and worthy opponent: Rick Blumberg, the Deputy Chief Counsel for Litigation at FDA, who died Thursday, March 7th, of complications from a stroke. He handled litigation for FDA for more …
