Friday, March 6, 2015

FDA Announces Workshop on Companion Diagnostics Policy: March 24, 2015

FDA has scheduled a public workshop entitled “Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies.”

The objective of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized medicine; and help incorporate emerging scientific findings to harmonize companion diagnostics across a class of targeted therapies.

The FDA workshop will be co-sponsored by the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO).

Date and Time: March 24, from 8:30 to 4:30.
Location:  Mayflower Hotel, Washington DC

Federal Register announcement, here.  ASCO's announcement, here.

CMS is holding a MedCAC (public advisory panel) on genomic tests on the same day (here).

Note that the FDA carefully refers to "drug and device" development - LDT's are "devices" here.