ABSTRACT
The 1990s have brought us the era of FDA regulatory reform. The law, the regulations, and the agency itself have undergone a tremendous change. The Center for Biologic Evaluation and Research (CBER) has undergone some of the most significant changes. As former FDA Commissioner David Kessler, M.D., had wanted, the drug and biologic approval processes have become very similar. Gone forever is the two-license system, the responsible head designation, and all the many other things that had made the biological approval process so unique and distinct and so different from drugs.
