The FDA carried out several actions, including: performing an external review of the existing CGMP program and
product review practices; encouraging innovation within the existing framework of statutory provisions and regulations
by allowing certain changes in the manufacturing process without prior review or approval (e.g. comparability
protocols); shifting the lead agency on implementation of 21 CFR Part 11 to the FDA’s Center for Drug Evaluation and
Research (CDER); and having FDA centers provide a scientific and technical review of all drug CGMP warning letters.
