Understanding Combination Product Regulations

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.

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).