Understanding Combination Product Regulations

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology, Regulatory Sourcebook, September 2021, Volume 2021 eBook, Issue 3

Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.

The variety of drug-device combination products continues to grow as the trends toward self-administration and personalized medicine drive development of these dosage forms, such as prefilled syringes and auto-injection devices. 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.

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Read this article in Pharmaceutical Technology’s September 2021 Regulatory Sourcebook eBook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook
September 2021
Pages: 4–7

Citation

When referring to this article, please cite it as J. Markarian, “Understanding Combination Product Regulations,” Pharmaceutical Technology Regulatory Sourcebook eBook (September 2021).