Sixth Acquisition Extends Veranex Lead in MedTech Industry Services
Veranex expands global capabilities for human-centered design, innovation, and strategy RALEIGH, N.C.; Dec. 7, 2021 – Veranex, the only global, tech-enabled...
How Long Does It Take to Register a Medical Device/IVD in China?
This article generalizes the process to provide a hyper-simplified answer for investors and CEOs, and sales & marketing executives of MedTech companies, needing this crucial piece of information to make…
Winter Has Come – Aggressive National Programs To Drive Down Drug Costs
China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along…
Defining the value of innovative treatment methods in Germany
A recent proposal by Jens Spahn, Federal Minister for Health in Germany, would limit the decision-making power of the Joint Federal Committee (G-BA) and lead to new evidence approaches for…
FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics
Earlier this month, the Food and Drug Administration announced a new draft guidance for companion diagnostics. The guidance describes considerations for the development and labeling of companion diagnostics to support…
Regulatory Approvals of LDTs
The Diagnostic Accuracy and Innovation Act (DAIA), introduced last year in the House of Representatives, would allow the Food and Drug Administration (FDA) to regulate laboratory developed tests with a…