With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue. Although the issue …
A few weeks ago, we blogged about FDA’s final rule amending the “intended use” regulation. The final rule looks very different than the proposed rule, and adopts a new “totality of the evidence” standard that does not resolve the old problems with the regulation but …
Some lawyers old enough to remember carbon paper may also remember, in their archaic law school teaching, the “eggshell plaintiff” rule, accurately described as “a maxim that a tort defendant takes his victim as he finds him.” Also referred to as the “eggshell skull rule,” …
Every year, hundreds of rare disease patients and caregivers descend on Capitol Hill to participate in Rare Disease Week to learn about federal legislative issues, meet other advocates, and share their unique stories with legislators. As part of this, on March 2, 2017, Hyman, Phelps …
Believe it or not, Hyman, Phelps & McNamara, P.C.’s FDA Law Blog turns 10 years old today (Monday, March 6, 2017). Where have all of the years gone? It seems like Tuesday, March 6, 2007 was just yesterday. That’s when we put up our initial …
Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and …
In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …
Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen. As we explained here, Genentech sued Amgen for failure to comply with the patent dance provisions …
In the absence of blogworthy FDA regulatory pronouncements (draft regulations, draft guidances, and oxymoronically named “tentative final rules”), material for FDA Law Blog posts is harder to come by these days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a …
Ten years ago, Congress commanded FDA to ease the burden of Medical Device Reporting (MDR) for most class I and class II devices. Four years ago, we blogged about it here. FDA still has not gotten it done. Specifically, Section 227 of the Food and Drug …
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 29th iteration, is back in New York at the Millennium Broadway Hotel on March 22-24, 2017. The conference is billed as the premier event to provide folks with a roadmap to navigate the …
On February 15, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. As described in previous blog posts, since FDA’s issuance of a warning letter to Kind LLC in March of …
FDA recently released a report summarizing its enforcement activities for FY 2016 (October 1, 2015 to September 30, 2016). It shows, among other things, that the number of warning letters from the Center for Drug Evaluation and Research doubled (76 in FY 2015 to 151 …
Last month we reported that the Hemp Industries Association (“HIA”) petitioned the U.S. Court of Appeals for the Ninth Circuit to block the Drug Enforcement Administration’s (“DEA’s”) implementation of its recent final rule on marijuana extracts. On February 6, 2017, HIA filed another action with …
A few months ago, we blogged on the DEA Acting Administrator’s use of official notice in final orders. Specifically, we questioned the Acting Administrator’s recent practice of relying on facts outside of the record (typically publically available state pharmacy board records) without taking official notice …
