The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product ...

The success of Boston Scientific's Taxus drug-eluting stent helped boost combination products' popularity. However, the regulatory requirements for such products are strict. Who Will Be the Lead ...

Packaging Extra Effort: Packaging for Combination Products Producing a suitable package for a combination product requires device companies to understand the regulations, materials, and processes ...

Dublin, Dec. 23, 2025 (GLOBE NEWSWIRE) -- The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course ...

Please provide your email address to receive an email when new articles are posted on . The draft guidance cited recent cases of contaminated products and made recommendations to improve safety. The ...