Pharmaceutical Technology - September 2021


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4 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Regulatory Oversight T he variety of drug-device combination products contin- ues to grow as the trends toward self-administration and personalized medicine drive development of these dosage forms, such as prefilled syringes and auto-injection de- vices. Pharmaceutical Technology spoke with Adam Lambert, PhD, vice-president of product and process development at Pharmatech Associates, about current regulatory considerations and best practices in developing combination products. Regulatory issues PharmTech: What is the regulatory definition of a combination product? Lambert (Pharmatech Associates): The regulatory definition of a com- bination product can be complex. Fundamentally, a combination product is defined [by FDA] as 'A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/bi- ologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity' (1). FDA has identified nine different types of combination products: convenience kit or co-package, prefilled drug delivery device/sys- tem, prefilled biologic delivery device/system, device coated/ impreg- nated/otherwise combined with drug, device coated or otherwise combined with biologic, drug/biologic combination, separate prod- ucts requiring cross labeling, possible combination based on cross labeling of separate products, and other combination products (2). PharmTech: How are applications for combination products submit- ted for regulatory approval? Understanding Combination Product Regulations Jennifer Markarian Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device. SAHAIDACHNYI ROMAN - STOCK.ADOBE.COM

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