JD Supra

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...
JD Supra

Will Patent Classification Harmonization Based On The Cooperative Patent Classification System Strike A Chord?

As mentioned in my previous post on the Cooperative Patent Classification system (CPC), the International Patent Classification system (IPC), on which the CPC is based, is used by more than 100 patent ...
IPWatchdog

The CRISPR Battle Through the Lens of International Patent Harmonization

“In the end, the Federal Circuit faces a momentous decision: Affirm the PTAB’s status as an apparent international outlier—thereby denying the Nobel Prize winners—or reverse the PTAB, which can be ...
BioWorld

Indonesia formalizes medical device risk registration system for ASEAN harmonization

HONG KONG – Indonesian regulators have introduced a medical device risk classification system, as part of a harmonization of regulations across the Association of Southeast Asian Nations (ASEAN) ...
The National Law Review

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...