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 …
Hyman, Phelps & McNamara, P.C. ("HP&M") will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP’s mission is to provide an open public forum for policy makers and …
Hyman, Phelps & McNamara, P.C. Director David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products. The conference, titled “EU and US Regulatory Issues for IP Professionals,” will take …
By William T. Koustas – The Federal Trade Commission (“FTC”) has amended its Red Flags Rule (“the Rule”) to comply with the Red Flag Program Clarification Act of 2010 (“Clarification Act”). As we have previously reported, the Fair and Accurate Credit Transactions Act of 2003 (“FACT …
On December 12th and 13th, the Food & Drug Law Institute (“FDLI”) will hold its annual conference on “Enforcement, Litigation and Compliance.” This year’s conference will be held at the Westin Georgetown hotel in Washington D.C. It will include quite a few government presenters on …
Hyman, Phelps & McNamara’s Robert A. Dormer will be speaking at the American Conference Institute’s upcoming conference, “Orphan Drugs and Rare Diseases – Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.” The conference will take place on November 28th and 29th …
