Topic
FDA Approval
198 published works
Napoli Shkolnik Blog
Possible FDA Crackdown Against CBD Products
December 3, 2019 | Pharmaceutical Litigation The Food and Drug Administration told over a dozen companies to stop selling cannabidiol-infused food products and stop making inflated health claims about their…
Focus on Regulation
European Medicines Agency’s new guide on the wording of therapeutic indication
By Elisabethann Wright, Grégoire Paquet
1. Introduction On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in…
Healthcare Law Blog
FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence
On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals…
Focus on Regulation
New drug marketing applications: how do EMA and FDA compare?
By Elisabethann Wright, Grégoire Paquet
1. Introduction A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in…
Future Lawyer
KardiaMobile 6L | 6 Lead EKG Wherever You Are
By rickgeorges
KardiaMobile 6L | AliveCor. I have upgraded my Kardia device to the 6L. While a single lead EKG is handy for identifying arrithmias, a complete picture of the heart requires…
DC Medical Malpractice & Patient Safety Blog
For patients’ sake, U.S. must slap down Big Pharma chiseling on tests, trials
Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back —…
The Continuum of Risk
Azim Chowdhury Interviewed by Regulator Watch About the American Academy of Pediatrics v. FDA Case
Azim Chowdhury was interviewed by "Regulator Watch" regarding the recent court case, American Academy of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 81652 (D. Md. May 15, 2019). To watch the…
Drug & Device Law
Michigan’s Product Liability Immunity Statute Remains an Absolute Defense
This post comes from the Cozen O’Connor side of the blog. Michigan’s product liability statute says that a drug is neither defective nor unreasonably dangerous, and the manufacturer and…
Employment & Labor
Second Circuit Upholds District Court’s Choice of Equitable Remedies Under ERISA and Its Decision to Award Prejudgment Interest at the Federal Prime Rate
By Jean Tomasco
The Second Circuit Court of Appeals recently issued an opinion in Frommert v. Conkright, affirming a district court decision regarding appropriate equitable remedies under ERISA and the amount of prejudgment…
Health Care and Life Sciences
FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices,…