Last week FDA issued a final guidance, Unique Device Identification: Convenience Kits, which clarifies FDA’s interpretation of a convenience kit for purposes of UDI labeling requirements. We previously blogged on the draft version here. As our readers know, the unique device identification system regulations require …
FDA’s interpretation and application of the Best Pharmaceuticals for Children Act (“BPCA”), which provides for a 6-month add-on period of pediatric exclusivity has piqued our interest more than once over the years, leading to several posts (see, e.g., here, here, and here). We now have …
In 2016, the Animal League Defense Fund (ALDF) sued Hormel Foods Corporation, alleging that the company’s use of the terms “natural” and “no preservatives added” in advertising for its Natural Choice products violated the D.C. Consumer Protection Procedures Act. Plaintiff alleged that the these claims …
FDA’s nutrition labeling rules have defined most nutrients based on chemical structure. However, in light of evidence on allulose, FDA may need to reconsider that focus. Allulose is a monosaccharide, and the nutrition labeling regulation defines sugars as mono- and disaccharides. Thus, under the regulations, allulose …
As expected, Donald Trump has signed the Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839), which, among other things, amends the Medicaid Drug Rebate statute to impose penalties for misclassifying innovator drugs as non-innovator drugs to reduce rebates. We previously posted on this …
On April 16, the Food Safety & Inspection Service (FSIS) of USDA announced the publication of a proposed rule amending the labeling regulations for net content statements on meat and poultry. FSIS proposes to remove the requirement for dual declaration of net weight and net …
Last week FDA issued a final regulation regarding consumer antiseptic rubs. In 2016, FDA had proposed that 28 active ingredients, including triclosan, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. FDA requested but did not receive …
As it previewed back in December, the government formally filed its motion to dismiss the high-profile False Claims Act case against Gilead Sciences, Inc. This case has had a long history, beginning in 2010 when the Relators filed their original complaint. After investigation, in 2013, …
The 2019 Maryland Legislative Session closed on April 8th with an exciting development related to laboratory testing. As we previously reported (see here), Maryland law currently prohibits directly or indirectly advertising or soliciting for medical laboratories. Two bills were introduced earlier this year to address …
We have long posted about the government’s threats to hold individuals liable for actions taken on behalf of their companies, for example here, but these actions remain rare and typically are reserved for egregious, repeated, and intentional criminality. A recent indictment against two former executives, …
We sometimes use the term “act of Congress” when referring to something that is difficult or requires large effort to achieve. But, as nothing else has worked, a real act of Congress may be required to compel the Drug Enforcement Administration (“DEA”) to issue marijuana …
We previously posted about what the Agricultural Improvement Act of 2018 (commonly referred to as the Farm Bill) did, and did not, do with respect to “hemp” and CBD products derived from hemp. In that post, we noted that the Farm Bill did not preempt …
In a press release issued on April 3rd, FDA reiterated its warning to stem cell clinics (and implicitly to other HCT/P facilities that are benefiting from enforcement discretion), asserting that the agency has stepped up oversight over such facilities, and will be ramping up even …
The Senate on Tuesday passed H.R. 1839, a bill of Medicaid amendments that included new penalties for mis-categorizing a drug under the Medicaid Drug Rebate Program (MDRP). The bill already cleared the House on March 25, and is now headed to Donald Trump for signature. …
A cutting-edge aspect of digital health is software as a medical device (SaMD) that uses artificial intelligence and machine learning to improve its performance based on real world use and experience. Until earlier this week, FDA has said very little about how to handle the …
