Regulatory submissions and quality considerations for combination drug/ device products: A primer

6^th International Conference and Exhibtion on Pharmaceutical Regulatory Affairs and IPR

September 29-30, 2016 Orlando, USA

David Amor

Medgineering Inc., USA

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Combination drug/device products are emerging as a preferred therapy of choice for many physicians, spurred by a strong collaboration between pharmaceutical and medical device sectors. The FDA recently released 21 CFR Part 4 and guidance for industry and FDA guidance for industry: cGMP�s for combination products, which implements a framework for combo product regulation and quality. Combination product marketing submissions are governed primarily by the product�s Primary Mode of Action (PMOA) which is the product�s main therapy mechanism. If a manufacturer is unsure of a product�s PMOA, they may submit a Request for Designation (RFD) which prompts the FDA to issue a binding decision on the manner. Combo products are submitted according to the PMOA; PMOA of drug means a product will be go FDA�s CDER branch which will require an IND, ANDA, NDA or other scaled submission, whereas PMOA of device will usually be submitted to CDRH, which requires an Investigational Device Exemption (IDE) per 21 CFR 812.

Biography :

Email: david@medgineering.com