Educational Resources

PBL Blog

News | February 28, 2015

FDA Publsihes New Draft Guidance on Combination Products

by Aaron Burke

For anyone in the medical device or pharmaceutical fields, it’s important to stay up to date on current Good Good Manufacturing practices.

In January, the US FDA published a draft guidance updating the cGMP requirements for combination products. The guidance defines what a combination products is, and contains application requirements for specific types of combination products: prefilled syringes, drug-coated mesh, and drug eluting stents.

The guidance can be found on the FDA website: cGMP Guidance for Combination Products

Scroll Up