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FDCA
242 published works
Drug & Device Law
District of Minnesota Says Maybe to Failure to Update Claim
We have expressed our opinion on “failure to update” claims and have not hidden that we don’t think much of them. Failure to update claims were manufactured by plaintiffs in…
Above the Fold
The TTAB Affirms Refusal of Another CBD Mark on “Lawful Use” Grounds
On September 25, 2020, the TTAB issued a non-precedential decision summarily rejecting an applicant’s attack against an examining attorney’s refusal to register the mark NATURAL LEAF CBD LIVE BETTER NATURALLY…
The Daily Intake
Federal Judge Orders Permanent Injunction for Repeated FDCA Violations
On May 27, 2020, U.S. District Judge Edgardo Ramos in the U.S. District Court for the Southern District of New York entered an order of permanent injunction against two individuals…
Drug & Device Law
No FDCA-Based Negligence Per Se in Texas
By Bexis
Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion…
Global IP & Technology Law Blog
False Advertising Dangers Lurk in the Age of COVID-19 – Redux
By Adam Fox, David Elkins
As we previewed in our earlier post, the COVID-19 pandemic raises new and heightened false advertising concerns for companies seeking to capitalize through mentions of the virus in marketing or…
Drug & Device Law
A Couple of Things
By Bexis
Here are a couple of things that happened recently (and no, we don't mean a travel ban on Europe or the NBA cancelling the rest of its season). They’re not…
Life Sciences Legal Update
FDA’s Section 804 Prescription Drug Importation Program and 801(d)(1)(B) Guidance
By Kevin Madagan, Cori Annapolen Goldberg, Sung Park, Catherine David
On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section…
Kight on Cannabis
FDA Steps-Up CBD Enforcement With New Warning Letters
By Rod Kight
The FDA issued another round of warning letters to CBD companies this week. Editor’s note: In this article, Kight Law attorney Kamran Aryah discusses the latest round of warning letters…
AdLaw By Request®
The FDA and FTC Join Forces in Issuing Warning Letter to CBD Product Company
By Cori Annapolen Goldberg, Adam D. Brownrout, Erika Auger
On October 22, 2019, the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) issued a public statement regarding a joint warning letter sent to Rooted Apothecary,…
Drug & Device Law
Don’t Forget About OTC Express Preemption
Did you remember that there can be express preemption for over-the-counter drugs? We sometimes forget too, but there are really good reasons for that. The Food Drug and Cosmetic Act…