The US Food and Drug Administration (FDA) recently published new guidance titled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.” This guidance was created to help the industry distinguish which changes to a pharmaceutical firm’s manufacturing process must be reported to federal regulators under the Pharmaceutical Quality system.
In, Zachary Brennan’s article, he suggests the reporting mechanism is clear, but the FDA would ultimately like to resolve any confusion to alleviate any adverse impact on the industry. These impacts can include change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.
While the FDA intended to make this new guidance easier for industry professionals to recognize where to send their approvals, it still allows room for confusion.
To read Zachary Brennan’s full article click here.