Generic drug device combination products: Regulatory and scientific considerations.

Autor: Choi SH; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Stephanie.Choi@fda.hhs.gov., Wang Y; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Conti DS; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Delvadia R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Leboeuf AA; Office of Generic Drug Policy, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Witzmann K; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2018 Jun 15; Vol. 544 (2), pp. 443-454. Date of Electronic Publication: 2017 Nov 21.
DOI: 10.1016/j.ijpharm.2017.11.038
Abstrakt: Complex regulatory and scientific considerations exist for drug-device combination products submitted under an Abbreviated New Drug Application. The Agency has published several guidances to aid industry in the development of a generic drug-device combination product: providing recommendations on the types of studies necessary to establish bioequivalence, providing considerations on product quality and performance for certain types of device constituents, and most recently, providing tools to assess the proposed user interface when compared to the user interface of the Reference Listed Drug. In addition, the Office of Generic Drugs 1 has established a regulatory science research program intended to support projects that examine scientific questions relating to the development of generic combination products and their associated regulatory review. Several research examples are described within this article, which demonstrate how equivalence can be evaluated when the function of the device could potentially impact drug delivery. Moreover, this article provides an overview of regulatory recommendations and ongoing scientific research efforts to further develop guidances and ultimately improve public access to generic combination products.
(Published by Elsevier B.V.)
Databáze: MEDLINE
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