The road to market implantable drug delivery systems: a review on US FDA's regulatory framework and quality control requirements.

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dc.contributor.author Al-Jawadi, Sana en
dc.contributor.author Capasso, Pier en
dc.contributor.author Sharma, Manisha en
dc.date.accessioned 2020-02-11T23:06:13Z en
dc.date.issued 2018-12 en
dc.identifier.issn 1083-7450 en
dc.identifier.uri http://hdl.handle.net/2292/49931 en
dc.description.abstract The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevent the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review investigates pharmaceutical science literature and the United States Food and Drug Administration (US FDA) regulatory guidance to find how any IDDS is classified, regulated, and introduced in the market. The regulatory classification of any IDDS, as a 'drug', 'medical device' or a 'combination product', is the cornerstone in determining the regulatory pathway, which decides the quality control requirements preceding the marketing approval. IDDSs are generally recognized as combination products as they consist of two or more regulated components (drugs, medical devices or biological products) combined prior to use to function as a single entity. Although robust and defined US FDA regulatory pathways exist for each component independent of one another, the regulatory pathways for combination products are less formalized. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.relation.ispartofseries Pharmaceutical development and technology en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.subject Animals en
dc.subject Humans en
dc.subject Drug Implants en
dc.subject Drug Delivery Systems en
dc.subject Drug Evaluation, Preclinical en
dc.subject United States Food and Drug Administration en
dc.subject Marketing of Health Services en
dc.subject Quality Control en
dc.subject United States en
dc.title The road to market implantable drug delivery systems: a review on US FDA's regulatory framework and quality control requirements. en
dc.type Journal Article en
dc.identifier.doi 10.1080/10837450.2018.1509348 en
pubs.issue 10 en
pubs.begin-page 953 en
pubs.volume 23 en
dc.rights.holder Copyright: The author en
pubs.end-page 963 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Review en
pubs.subtype Journal Article en
pubs.elements-id 755215 en
pubs.org-id Medical and Health Sciences en
pubs.org-id Pharmacy en
dc.identifier.eissn 1097-9867 en
pubs.record-created-at-source-date 2018-08-08 en
pubs.dimensions-id 30084277 en


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