Fueled by an urgent need for diagnostic testing to respond to COVID-19, the in-vitro diagnostics market is experiencing explosive growth across Asia and around the globe.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
This mode of personalized medicine helps doctors make more informed decisions related to drug therapies.
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
On July 19 and 20, 2010, the Food and Drug Administration held a public meeting on regulatory oversight of laboratory-developed tests (LDTs). This is considered a major step in an ongoing debate on how best to handle two different, but often overlapping, sets of diagnostic tools in a manner that best serves patient safety and public health, while recognizing the realities of clinical practice and medical product development.
Stakeholder interest was intense. The original meeting space reached capacity and registration closed within two days, prompting FDA to shift the conference to a larger venue. Nearly 650 people attended, while 650 more watched via webcast. FDA’s sense of urgency on the matter was further suggested by the June 10 issuance of “it has come to our attention” letters to six genetic testing companies, followed by another 14 on the opening day of the conference itself.
What are the issues? Why the concern? What does it all mean, and where might the Agency go?