FDA Authorizes First At-Home Chlamydia, Gonorrhea Test
Simple 2 Test available OTC as first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV.
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The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.
The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.
As the US FDA works to finalize new regulation of lab-developed tests, it must consider more than two thousand comments that have poured into the agency since the proposed rule was published in October. The comment period closes Monday.