Although the FDA retains authority for drug approvals, advisory committees of non-agency experts review applications and safety studies, as well. However, finding members without conflicts of interest to serve on these committees is difficult for the FDA. Recently, Dr. Samuel Maldonado, Johnson and Johnson vice president and head of its Pediatric Drug Development Center of Excellence was asked to be removed from an advisory committee that was reviewing drugs for children, including Invega, which is manufactured by a J&J subsidiary. To read the full article, click here. Contact us at 317-899-9341 for help with your FDA regulatory filings.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.