US FDA this week backed away from proposals to directly regulate Lab Developed Tests, signalling an increased caution ahead of the new administration. But FDA has also said it intends to bring forward further proposals soon – and what does this mean for manufacturers seeking to market tests through LDT?
Archives for November 2016
The Asian Harmonisation Working party held its annual meeting in Cebu, Philippines this week. The Technical committee adopted a range of new guidances and AHWP continued to extend membership and promote training and capacity building activities. We take a look at the progress made over the past year.