By Jessica A. Ritsick & William T. Koustas – Over 25 years ago, the Prescription Drug Marketing Act ("PDMA") was passed. The PDMA called for implementation of a national system to follow prescription drugs through the supply chain. After years of talking about it (see here), …
By Riëtte van Laack – On November 7, 2013, the Food Safety and Inspection Service (FSIS) amended its prior label approval system regulations to expand the circumstances in which certain types of labels and labeling are generically approved and do not need specific FSIS approval. Under the …
By Jessica A. Ritsick & William T. Koustas – At this year’s Health Care Distribution Management Association (HDMA) annual track-and-trace conference, most minds were focused on one thing: the potential passage of H.R. 3204, the Drug Quality and Security Act, which would mandate a uniform, national, interoperable electronic …
On November 20th, the Food and Drug Law Institute ("FDLI") will present a webinar on the regulatory requirements that apply to health-related claims for foods. Hyman, Phelps & McNamara, P.C.'s Ricardo Carvajal will discuss requirements applicable in the U.S. Vicente Rodriguez, current president of the …
By Allyson B. Mullen – For many individuals, a diagnosis, be it life threatening or chronic, is scary. However, the trial and error process that can follow the diagnosis in order to find a therapy (e.g., drug, device and/or biologic) that works best for the patient …
By Dara Katcher Levy – A new Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) suggests that FDA may want a new fight when it comes to the issue of that pesky First Amendment and the interplay with FDA-regulated products. In a November 8, …
By Jennifer M. Thomas – The generic drug industry has waited with bated breath since, as we reported here and here, FDA signaled that it was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.” See …
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 …
By Etan J. Yeshua – The Food and Drug Administration last week initiated a process that could prohibit the sale of partially hydrogenated oils (PHOs), as well as food products containing industrially manufactured PHOs, such as certain baked goods, microwave popcorn, frozen pizzas, frostings, and …
An article published in the current edition of Regulatory Focus, the flagship publication of the Regulatory Affairs Professionals Society (RAPS), and authored by Hyman, Phelps & McNamara, P.C.’s Alexander J. Varond discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and …
The New York Academy of Sciences will present a conference on scientific and regulatory issues pertaining to nanomedicine on November 21. The conference will feature speakers from the U.S. and abroad so as to provide domestic and international perspectives. Hyman, Phelps & McNamara’s Ricardo Carvajal …
By Kurt R. Karst – Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of …
By Ricardo Carvajal – Colorado’s Department of Revenue recently published retail marijuana rules to implement that state’s Retail Marijuana Code (“RMC”). C.R.S. 12-43.4-101 et seq. The rules took effect on October 15, and are the culmination of a change in Colorado law that began with an …
By Jennifer M. Thomas – I have monitored the drug shortage issue over the last few years with professional interest and general concern (see here). However, the situation was recently brought home to me when I took my four-month old in for her second round of …
Postponed due to the partial government shutdown, this conference will address numerous compliance and enforcement issues of interest to dietary supplement manufacturers and distributors, and will feature discussion of the anticipated impacts of FSMA implementation. Senior FDA and state officials will provide their perspectives, …
