FDA Offers Advice on Making Changes to Disposable Manufacturing Materials

The FDA advises drug sponsors on how to communicate with the agency when they need to make postapproval changes related to disposable manufacturing materials, in a final guidance released Friday.

Such changes to disposable manufacturing materials can include changing suppliers, using similar materials that differ in composition or design, reducing the number of materials used or extending the use of materials in manufacturing by increasing throughput and reusing a disposable manufacturing material, the FDA said.

The agency said all changes to disposable manufacturing materials for approved drug products should be communicated to the FDA through postapproval submissions.

Comments on the guidance can be submitted at any time.

Read the final guidance here: bit.ly/3oEMXG1.