Antibiotic-resistant bacteria are claimed to be one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). …
On Monday, March 27, FDA and the Society of Toxicology (SOT) will present a colloquium (chaired by Bernadene A. Magnuson, PhD, Health Science Consultants, Inc., and Sabine Francke, DVM, PhD, CFSAN FDA) on Considerations for the Determination of Adversity in Food Chemical Safety Evaluations, the …
Oh Canada! Congress has decided that it’s once again time to start looking to our neighbors to the north for some help increasing accessibility and decreasing cost of prescription drugs. With two new bills introduced in the last month, one in each chamber of Congress, …
On Friday, Amgen submitted its Opening and Response Brief at the Supreme Court in the matter of Sandoz v. Amgen, Nos. 15-1039, 15-1195. The brief addressed two major questions with respect to the BPCIA: when an applicant can provide 180-day notice of biosimilar marketing and …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Andrew J. Hull & Mark I. Schwartz On Tuesday, the U.S. Court of Appeals for the Federal Circuit affirmed a preliminary injunction against Apotex Inc. and Apotex Corp. (collectively, “Apotex”) related to Apotex’s biosimilar version of Amgen Inc. and Amgen Manufacturing Limited’s (collectively, “Amgen’s”) NEULASTA …
By Allyson B. Mullen, Jeff N. Gibbs, McKenzie E. Cato* – Technological advances have resulted in Next Generation Sequencing (NGS) being used more and more frequently by diagnostic laboratories. NGS in vitro diagnostics (IVDs) present a new set of regulatory and technical challenges for FDA and …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Karla L. Palmer – The Government Accountability Office (GAO) issued three reports during 2015 making eleven recommendations to the Drug Enforcement Administration (DEA) to more effectively perform their functions under the Controlled Substances Act (CSA) and DEA’s implementing regulations (see previous posts here and here). GAO now reports that, …
By Karla L. Palmer – In FDA’s third draft guidance document in the past week related to drug compounding , FDA addresses hospital and health system drug compounding and distribution. FDA “regards a health system as a collection of hospitals that are owned and operated by …
This 1-day conference, scheduled for Tuesday, May 3, 2016 in Arlington, Virginia, is for individuals who draft or review documentation relating to the quality of products regulated by FDA. Effective documentation (written communications/company records) is critical to the success of any company, most especially any …
By Ricardo Carvajal – It’s getting hard to turn around without bumping into a Food Safety Modernization Act (FSMA) consultant. Perhaps it was inevitable, given the compliance dates that suddenly don’t seem so far away, the law’s many moving parts, and the mantra that FSMA is the most …
The Food and Drug Law Institute (FDLI) is holding a two day conference, titled “Enforcement, Litigation, and Compliance conference.” The workshop is this week, on December 9 and 10. Within the conference, Jeff Shapiro will participate in a medical device breakout panel focused on mHealth …
By Jay W. Cormier & Allyson B. Mullen – Two years ago, FDA promulgated the Part 4 regulations that specify how manufacturers of combination products are to comply with current good manufacturing practice (cGMP) when making products whose constituent parts are from more than one type …
