Combination Products Requirements and West Position – Regulatory White Paper
West's Regulatory position concerning constituent parts of Combination Products.
In order to fall within the 21 CFR Part 3 Rule, a product comprised of two or more regulated components (i.e. drug/device, biologic/device, drug biologic) must be physically, chemically or otherwise combined or mixed to produce a single entity combination product or co-packaged.
Please Signup/Login to see the full article.Click here