By Kurt R. Karst – After more than three years of litigation that started with a July 2010 Complaint filed in the U.S. District Court for the Southern District of New York (see our previous post here), and that went up to the U.S. Court of …
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By Kurt R. Karst – After more than three years of litigation that started with a July 2010 Complaint filed in the U.S. District Court for the Southern District of New York (see our previous post here), and that went up to the U.S. Court of …
The American Conference Institute will be holding its inaugural forum on controlled substances in Washington, D.C. from Thursday January 16 to Friday, January 17, 2014. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s John A. Gilbert will be …
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 …
By Kurt R. Karst – “Oddities” are not the sole domain of the world of antiques and other rarities (for those of you who are fans of the television show that focuses on the day-to-day operation of Obscura Antiques & Oddities). Food and drug law – …
By Kurt R. Karst – In what appears to be the first dismissal (Docket No. FDA-2012-E-0491) of a Patent Term Extension (“PTE”) application in what has been referred to as a “reverse Photocure” scenario, the Patent and Trademark Office (“PTO”) has determined that U.S. Patent No. …
By John A. Gilbert & Delia A. Stubbs – In a decision published this week, DEA denied an application for a pharmacy registration on the basis that the owner-pharmacist had previously ignored “red flags” and generally failed to exercise her corresponding responsibility in filling prescriptions. Wheatland …
By Karla L. Palmer – On Monday, November 18, 2013, DEA released the 2013 National Drug Threat Assessment Summary, which provides an assessment of the threat posed to the United States by trafficking and abuse of illicit substances and non-medical use of controlled prescription drugs. The …
By Karla L. Palmer – As reported here yesterday on the track and trace provisions, after many months of legislative maneuvering and various iterations emanating from both the House and Senate, the Senate passed without amendment and by voice vote H.R. 3204 – the “Drug Quality …
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. …
The American Conference Institute will be holding its inaugural forum oncurrent Good Manufacturing Practices (“cGMPs”) in Washington, D.C. from Thursday, January 23 to Friday, January 24, 2014. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Douglas B. Farquhar …
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 …