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 …
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Hyman Phelps McNamara
- A Three-peat: U.S. News & World Report Ranks HP&M as Top Tier FDA Law FirmNovember 15th, 2012
- 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 …
- With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme CourtNovember 14th, 2012
By Kurt R. Karst – Back in August, we posted on a Petition for Writ of Certiorari filed by Mutual Pharmaceutical Company, Inc. (“Mutual”) appealing a May 2, 2012 decision from the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical …
- The Toxin in Ackee: Naturally Occurring? Added? Does It Matter?November 13th, 2012
By Ricardo Carvajal – FDA published a draft Compliance Policy Guide ("CPG") that sets out enforcement criteria for ackee fruit products that contain hypoglycin A, a toxin that is naturally present in the fruit. Adverse effects of consuming the toxin can range from none to vomiting, …
- FDA Presses “Heckler Defense” in Appeal of Unapproved Thiopental Sodium Death Row Inmate CaseNovember 12th, 2012
By Kurt R. Karst – FDA’s opening brief in the Agency’s appeal of a March 27, 2012 Memorandum Opinion and accompanying Order issued by Judge Richard J. Leon of the U.S. District Court for the District of Columbia (as modified by a June 22, 2012 …
- A Congressional Hearing: “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” Is Scheduled for Wednesday, November 14, 2012November 12th, 2012
By Karla L. Palmer – The Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations issued a Majority Memorandum announcing that it is holding a hearing titled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” The hearing will begin at 10:00 am at Room …
- Here Comes the Pitch, He Swings, and a Miss! OPDP Issues Untitled Letter for Media PitchesNovember 11th, 2012
By Jeff Wasserstein & Dara Katcher Levy – FDA’s Office of Prescription Drug Promotion (“OPDP”) recently issued an untitled letter to Cornerstone Therapeutics, Inc. relating to Cornerstone’s drug Curosurf (see here and here). The allegations in the letter are unremarkable and contain the usual claims …
- Does a Hatch-Waxman Patent Delisting Counterclaim Terminate a 30-Month Litigation Stay?November 8th, 2012
By Kurt R. Karst – From time to time throughout Hatch-Waxman history the question has come up: What court decisions terminate a 30-month litigation stay arising as a result of a timely filed patent infringement action in response to a Paragraph IV certification (in either …
- CDRH Reorganizes its Office of Device EvaluationNovember 7th, 2012
By Jennifer D. Newberger – CDRH recently announced that, as of November 1, 2012, the Office of Device Evaluation ("ODE") has been reorganized. There are two new divisions—the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices—and 12 new branches across all …
- “New” CDER Exclusivity Board Focuses on Clarity and Consistency of Exclusivity DecisionsNovember 6th, 2012
By Kurt R. Karst – FDA recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of …
- Congressman Markey Introduces Legislation Increasing Regulatory Oversight of Pharmaceutical CompoundingNovember 5th, 2012
By Karla L. Palmer – In the wake of the New England Compounding Center (“NECC”) matter, on November 2, 2012, Congressman Edward J. Markey (D-MA), senior member of the Energy and Commerce Committee, introduced legislation that will attempt to strengthen federal oversight of compounding pharmacies. NECC, …
- Expedited Entry of Imported Foods Remains a Gleam in Importers’ EyesNovember 5th, 2012
By Ricardo Carvajal – The Government Accountability Office ("GAO") published a report that examines FDA’s progress in implementing provisions of the Food Safety Modernization Act ("FSMA") that direct the agency to establish a third-party certification system for imported foods. Among other things, that system is a …
- HP&M’s Frank Sasinowski Gives Keynote at Symposium on Eosinophilic DisordersNovember 5th, 2012
Frank Sasinowki, Director at Hyman, Phelps & McNamara, P.C. and board member of the National Organization for Rare Disorders ("NORD"), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s ("CURED’s") first research symposium on eosinophilic gastrointestinal disorders ("EGID"). CURED is a …
- Job Opportunity: HP&M Seeks Attorney with Food, Dietary Supplement, and OTC Drug ExperienceNovember 1st, 2012
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an associate with three to five years experience in food, dietary supplement, and OTC drug laws and regulations to assist with a growing practice. Experience in regulation of labeling …
- Excuses, Excuses! A Round-Up of Exceptions Under the Failure to Obtain Timely Tentative Approval 180-Day Exclusivity Forfeiture ProvisionNovember 1st, 2012
By Kurt R. Karst – The recent lawsuit filed against FDA in the U.S. District Court for the District of Columbia in which Mylan Laboratories Limited and Mylan Pharmaceuticals Inc. are challenging FDA’s decision that Ranbaxy Inc. is eligible for 180-day exclusivity for its generic …