Viewing posts categorised under: Regulatory

Regulatory Strategy for In Vitro Companion Diagnostic Devices

Final FDA Guidance for In Vitro Companion Diagnostics (CDx) was released in August, providing direction for companies seeking to define a regulatory approach to this booming opportunity. According to Transparency Market Research, the global CDx market is expected to be valued at $5.6 billion in 2019 with a CAGR of 18.1% from 2013 to 2019 […]