The guidance is the first of several that will cover the new medical device and in vitro diagnostic regulations, which are set to come into force by 2020 and 2022, respectively.
The guidance advises sponsors to work with the agency to create a development plan for the drug and test early on so they are reviewed and launched around the same time.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
While companies are expected to have their IVDs certified under the new regulation by 2022, manufacturers are frustrated by the slow pace of the certification process.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
The protocol could lead to greater regulatory harmonization in Europe, where every country has its own national legislation covering genetic testing.
The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.
In a new guidance, the US regulatory agency encouraged voluntary inclusion of LOINC codes with IVDs as a means to promote data interoperability.
The initial focus will be on Zika and chikingunya, and will leverage iBio's antigen and antibody manufacturing capabilities for product prototype development.
The findings run counter to historical data and may provide fodder to reconsider current guideline recommendations on surveillance of colorectal cancer patients.