FDA Repeals GST Regulations, Plans on Removing Obsolete Biologics Procedures

The FDA is revoking general safety test requirements that are duplicative in biologics licensing applications and proposing to remove two obsolete regulations for the review and reclassification of biologics licensed before July 1972.

In a final rule, the FDA is removing GST requirements regarding inactivated influenza vaccine, allergenic products and the detection of extraneous toxic contaminants in certain biological products intended for humans.

However, jettisoning the regulations does not remove GST requirements specified in individual BLAs, the FDA notes. Biologics makers will still need to perform GSTs unless their BLA is revised through a supplement to eliminate or modify the test.

In comments on the rule, BIO called the decision positive because it reduces the use of animals and eliminates the use of an assay that’s no longer needed to ensure the safety of products based on more advanced testing.

The regulations on review and classification procedures for products licensed before July 1, 1972, are no longer necessary due to new regulations to assess and ensure product safety and efficacy, the FDA says. These include current good manufacturing practice regulations on the preparation of biologicals, labeling, reporting of product deviations and postmarket reporting of adverse events.

Comments on the proposed rule are due Sept. 30. Read the proposed rule to remove obsolete regulation and the final rule revoking safety test requirements at www.fdanews.com/7-15-FDA-Rule.pdf  and www.fdanews.com/07-15-FDA-Rule2.pdf, respectively. — Jonathon Shacat