Viewing posts categorised under: Regulatory-affairs-2

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 […]

FDA Breakthrough Therapy Designation: A Pathway for Expedited Drug Development

On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. This Act is intended to expedite the development and review of drugs targeting serious or life-threatening indications. A drug awarded the FDA Breakthrough Therapy designation is: intended alone or in combination with one or more other drugs to […]

New FDA Guidance – A Risk-Based Approach to Monitoring Clinical Trials

As clinical trials have become increasingly complex, clinical trial oversight has become more difficult to standardize. In response to this challenge, the FDA recently issued a new guidance that aims to assist sponsors of clinical trials in developing monitoring strategies that utilize a risk-based approach. While no single monitoring approach is appropriate for each and […]