Veranex Blog

FDA Regulatory (2)

2 min read

Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule

On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...

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5 min read

Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment

Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...

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3 min read

Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development

Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...

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2 min read

Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)

Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...

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2 min read

The New Normal for Market Access in China: Volume Based Procurement

Our previous update1, Analysis of China’s First National Tender on Coronary Stents, discussed the first national-level centralized tender for a...

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2 min read

Medical Writing in Early Phase Studies

Is specialized knowledge needed for Medical Writers working on early phase studies? Based on the characteristics and needs of Phase 1, 1a, 1b, BA-BE...

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2 min read

FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics

April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro...

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1 min read

The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?

In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...

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