On Dec. 18, 2018, the Center of Veterinary Medicine (CVM) of FDA announced the publication of its 2017 Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This report is required by the Animal Drug User Fee Amendments of 2008. Under that law, …
On December 20, 2018, the Agricultural Marketing Service announced the availability of its long-awaited final rule implementing the national mandatory bioengineered (BE) food disclosure standard (NBFDS). The history of the law and rule was discussed in our post on the proposed rule. In the proposed rule, AMS …
For the first time, FDA formally recognized a public database containing information about genes, genetic variants, and their relationship to disease. FDA announced its formal recognition of the genetic variant information in Clinical Genomic Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data, a database …
In a rare display of bipartisanship in Washington, Congress has passed, and the President has signed, the Agricultural Improvement Act of 2018. The agricultural legislation is far-ranging, but its most significant aspect from a controlled substance perspective is that it removes “hemp” as defined in the …
Drug and device manufacturers that sell FDA-approved products reimbursed by the federal government should stay abreast of the pending Supreme Court petition in United States ex rel. Campie v. Gilead Sciences, Inc. (the factual and procedural background is summarized here and here). In short, the …
On December 18, 2018, FDA published in the Federal Register a new docket entitled, “Notice of Intent to Consider the Appropriate Classification of Hyaluronic Acid Intra-articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence.” This document is quite …
As we previously reported, one of the main components of FDA’s 2016 final rule to update the Nutrition Facts is the mandatory requirement for a declaration and a daily value (DV) for “added sugar” for both sugars added to processed foods as well as foods “packaged as …
On December 13, 2018, the National Academies of Sciences, Engineering, and Medicine released the proceedings of a May 2018 expert workshop entitled “Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda”. The workshop, hosted by the Academies’ Forum on Drug …
FDA issued its final Guidance on Data Integrity on December 12. The federal government has sworn off regulating by guidance (see blogpost here about Brand memo). In fact, at the Food and Drug Law Institute (FDLI) Enforcement and Litigation Conference that was occurring simultaneously with …
On December 4, 2018, FDA issued a proposed rule that would govern the de novo classification process. After a comment period, it may be re‑issued as a final rule to take affect 90 days after publication. While we agree with FDA’s goal of creating greater …
On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018). We have previously blogged about the case here, here, and here. In a nutshell, Shire …
Duodenoscopes are flexible, lighted tubes that are threaded through the body into the top of the small intestine (duodenum) and allow doctors to see potential problems in the pancreas and bile ducts. Because duodenoscopes are reusable devices, they must be reprocessed (cleaned) after each use …
On Friday, the Yale Law School Media Freedom and Information Access law clinic filed a complaint against FDA, HHS, and NIH alleging violations of the Administrative Procedure Act based on Section 801 of the FDA Amendment Act (FDAAA), which requires results reporting of clinical trials …
On Dec. 6, FDA announced that it is formally seeking data, comments and information related to the assessment of safety and effectiveness of food handler antiseptic drug products (rubs and washes) for over-the-counter (OTC) use. Although this is a positive development, judging from the questions …
Hard to believe that just two years ago, ev3, Inc. scored a resounding victory after the First Circuit affirmed the dismissal of a qui tam action against it (we reported it here). This week, DOJ announced that the same company has agreed to a criminal …
