Medmarc Blog (blog.medmarc.com)
Pharmaceuticals (2)
AdvaMed Revises its Code of Ethicsitle Here...
The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The...
FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)
On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from...
FDA Released Finalized Guidance Document for Combination Products
In January 2022, FDA released a new final guidance document titled, ‘Principles of Premarket Pathways for Combination Products’ which has caused many manufacturers to reevaluate their FDA...
Are You Remanufacturing or Servicing the Product?
On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices. With this guidance, the FDA aims to distinguish between remanufacturing and servicing and to instruct the...
Is My Product a Drug or a Device? The D.C. Circuit Court Weighs in on this Question
There are several important differences between FDA regulations of pharmaceuticals and medical devices. These differences span from regulation of promotion and advertising to the testing...
FTC Moves Aggressively on Rulemaking and Mergers
The U.S. Federal Trade Commission has undertaken several decisive moves since the beginning of the year, including the formation in March of a multi-lateral work group for mergers in the...
Churn at Justice as Drug Pricing Rule Falters Again
Bipartisan supporters of drug pricing transparency in the U.S. absorbed another blow when an appeals court rejected the Trump administration’s drug price transparency rule as lacking statutory...
An Overview of Liability Immunity for Products Meant to Counter COVID-19 Under the PREP Act
Device manufacturers (as well as drug manufacturers, distributors, and health care providers) are struggling to answer many questions regarding their potential products liability in responding...