Proposed FDA Rule Gives More Flexibility for Biologics Testing

The FDA is proposing amendments to its sterility testing requirements for biologics to give industry greater flexibility and encourage use of technologically up-to-date testing methods. The elimination of specific — in some cases, outdated — requirements in 21 CFR Parts 600, 610 and 680 would recognize current practices while allowing manufacturers to take advantage of modern sterility test methods, the FDA said.
Washington Drug Letter