Jeffrey N. Gibbs

CDRH Issues Final Guidances Regarding Use of Real-World Evidence and Procedures for Advisory Committee MeetingsSeptember 13th, 2017
It appears that CDRH has now resumed issuing guidances after not issuing any in the first six months of the new administration. In late August and early September CDRH has issued several final guidances, including “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical …
No Final LDT Guidance, But FDA Provides Insight into What a Future Guidance Might ContainJanuary 26th, 2017
In late November, FDA announced that it would not be finalizing the 2014 draft LDT Guidance. The Agency had, however, done a significant amount of work regarding the draft guidance and evaluating the regulatory framework for lab tests. In an effort to document the work …