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 …
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Miscellaneous
- D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA RequestsApril 9th, 2013
- George Miller Burditt, Requiescat in PaceMarch 18th, 2013
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, …
- In Memoriam: Eric (“Rick”) M. Blumberg, FDA’s Deputy Chief Counsel for LitigationMarch 8th, 2013
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 …
- Last Call: HP&M Webinar on Real-World Implications of United States v. CaroniaJanuary 30th, 2013
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. …
- HP&M’s Diane McColl Tapped as New President of the International Society for Regulatory Toxicology and PharmacologyDecember 25th, 2012
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 …
- HP&M’s Dave Clissold to Speak at Management Forum Conference on Drug Regulatory Strategy MattersDecember 21st, 2012
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 …
- Red Flags Rule Comes BackDecember 5th, 2012
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 …
- HP&M to Speak at Next Week’s FDLI Enforcement ConferenceDecember 4th, 2012
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 …
- Robert Dormer to Speak at ACI Orphan Drugs and Rare Diseases ConferenceNovember 20th, 2012
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 …
- A Three-peat: U.S. News & World Report Ranks HP&M as Top Tier FDA Law FirmNovember 15th, 2012
For the third year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of “FDA Law” by the folks over at U.S. News & World Report, who once again teamed up with Best Lawyers …
- HP&M’s Dave Clissold to Speak at Management Forum Conference on Orphan Drug, Regulatory Strategy Matters, and MoreNovember 15th, 2012
Hyman, Phelps & McNamara, P.C. is pleased to announce that 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 …
- Hyman, Phelps & McNamara, P.C. Names Two New DirectorsOctober 31st, 2012
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Dara Katcher Levy and Anne K. Walsh have been named Directors of the firm. Ms. Levy devotes a significant portion of her practice to the review of launch and post-launch promotional materials, and also …
- The Obesity Epidemic: FDA’s Growing Waistline!September 3rd, 2012
By Kurt R. Karst – One recent afternoon we returned to our office from a meeting to find the new (2012) nine-volume set of Title 21 of the Code of Federal Regulations (“CFR”) placed on our desk chair. There’s a special place on our desk …
- The Rabbit Hole Runs Deep; CDRH “Whistleblower” Scandal Involves a Once-Secret qui tam LawsuitAugust 26th, 2012
By James R. Phelps – According to recent reports concerning the widely reported “whistleblower” scandal at FDA’s Center for Devices and Radiological Health (“CDRH”), in 2009, the CDRH dissidents involved in the affair, while still employed at FDA, filed a “secret” Federal False Claims Act suit …
- The ABA Blawg 100 – We Need Your Nominations!August 13th, 2012
It’s that time of year again when we at FDA Law Blog turn to our loyal readers and ask for your help. The American Bar Association (“ABA”) announced that it is now accepting nominations for the 2012 Blawg 100 (the top 100 legal blogs – …