“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
Woodcock was selected by outgoing Commissioner Stephen Hahn, M.D.
Understanding the GMP requirements of each component is critical to product and compliance success.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.