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In January, the US FDA published a draft guidance updating the cGMP requirements for combination products.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