West Pharmaceutical Services : Speeding Review and Approval – FDA Emerging Technology Program
June 22, 2017 at 10:04 am EDT
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Speeding Review and Approval - FDA Emerging Technology Program
Are you familiar with the U.S. Food and Drug Administration's (FDA's) new Emerging Technology Program (ETP)? The aim of ETP (created through the Center for Drug Evaluation and Research's Office of Pharmaceutical Quality) is to promote adoption of new approaches to pharmaceutical product design/manufacture that can improve safety, identity, strength, quality or purity.
The FDA recognizes that new approaches may present both regulatory and technical challenges, and that pharmaceutical companies will have concerns regarding delays resulting from the need for FDA reviewers to become conversant with these approaches. Therefore, a key element of ETP is the Emerging Technology Team (ETT), which comprises experts from all FDA quality functions who can address applicants' questions.
Now - well in advance - pharmaceutical companies can have a formal pre-submission (Type C) meeting with ETT to identify, discuss and resolve potential concerns with a new approach. This will lead to more efficient review and approval. Examples of new approaches addressed with ETT are:
Continuous manufacturing of small-molecule drug products
Pharmacy on demand (small manufacturing platform for continuous bioprocessing)
Emerging technologies that can cross multiple platforms (e.g., use of robotics in fill/finish operations, and use of novel container and closure systems for injectable drug products)
If you are interested in better understanding ETP, and how it may benefit your organization, click here.
West Pharmaceutical Services Inc. published this content on 20 June 2017 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 22 June 2017 14:04:03 UTC.
Original documenthttp://www.westpharma.com/en/blog/2017/June/fda-emerging-technology-program
Public permalinkhttp://www.publicnow.com/view/88825EF2A68732C077C04ABC355FF2D14667C9B3
West Pharmaceutical Services, Inc. specializes in the design, manufacture and marketing of components and systems for the containment and delivery of injectable drugs. The group offers packaging, components for syringes, cartridge systems, auto-injection devices, accessories for vials, specialty components, etc. Net sales break down by family of products as follows:
- own manufactured products (81.8%);
- products manufactured under contract (18.2%).
Net sales are distributed geographically as follows: the United States (42.3%), Germany (16.8%), Ireland (8.7%), France (7.5%), Europe (12.1%) and other (12.6%).
WEST PHARMACEUTICAL SERVICES, INC. 
