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 …
It was just a couple of weeks ago that we published a post titled “Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a ‘Route of Abuse’ Approach to Exclusivity.” Among other things, we discussed Egalet US, Inc.’s ARYMO ER (morphine sulfate) Extended-release Tablets, …
On Inauguration Day (January 20, 2017) President Trump’s assistant Reince Priebus circulated a regulatory “freeze order” blogged here affecting regulations and guidance published in the Federal Register but that had not yet taken effect, postponing their effective date for 60 days (from January 20, 2017). The …
In 2015, FDA proposed revising the so-called intended use regulation (21 CFR 201.128; id. § 801.4) to remove the famous “knowledge” sentence: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce …
2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on …
On January 18, 2017, the U.S. Department of Health and Human Services along with 15 other federal agencies issued the Final Rule to revise the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” This 1991 set of regulations created a …
DEA’s administrative docket is off to a quiet start this year. Since January, the Administrator has issued five final orders, all of which are so-called “loss of state authority” cases. In these cases, the Administrator adjudicates, as a matter of law, that a practitioner’s DEA …
FDA’s Field Alert Report (or FARs) reporting requirements are authorized under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i) in 1985. The regulatory provision states, in part, …
Just a few days before the presidential inauguration, FDA published a revised draft guidance on control of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods. The significance of the guidance to the food sector is difficult to overstate. Since FDA published the original draft guidance in February …
It has become almost commonplace to see a weekly announcement of a False Claims Act settlement by a major pharmaceutical or medical device manufacturer. Perhaps that is why last month’s settlement by Baxter Healthcare Corporation flew under the radar of the FCA bar. Or perhaps …
