Search results for " review"
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Manufacturers Struggle with Breakthrough Drug Development
Such designation brings considerable FDA assistance in developing accelerated test protocols and in speeding an application through the review process. The designation also plays well on Wall Street, …
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A Look Ahead at BioPharma Manufacturing and Regulation
Part of this initiative identifies specific standards, methods, and questions for drug reviewers to use in their review process. The overall effort builds upon the agency's Critical Path Initiative, l…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Regulatory flexibility
In addition to remote field inspections, FDA review staff organized virtual meetings with medical product sponsors to assess and devise appropriate, yet more flexible R&D …
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Reliability Rooms and the Move to Proactive Supply Chain Management
It ensures that employees from different functions, each with different perspectives, review performance and escalate issues or near-misses to identify their root causes and identify any risks that mi…
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Design and Qualification of Single-Use Systems
With increasing regulatory oversight of SUT processes, it’s worthwhile to review basic concepts of design and qualification that apply to single-use components and systems (SUS).
Equipment Design …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Each element of the justification needs to be reviewed and evaluated during the cleaning process design stage to defend a lean approach in continuously monitoring the cleaning process. A risk-based ap…
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The Metrics of Quality Culture
In some cases, the specified metrics are also reported to the agency via the annual report or are contained in the annual product review. The bio/pharma industry needs to review these metrics and ensu…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Appropriate control of CQAs is a common review concern for both investigational new drug (IND) and license applications.6,7 Product quality characteristics encompass a wide variety of product variants…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
…est practices to navigate the regulatory approval path
9:44 - The impact of filing accelerated review applications on process development
11:41 - What quality teams should do to ensure qu…
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Modern Manufacturing Key to More Effective Vaccines
FDA is applying lessons learned from Ebola to streamline vaccine development, noted Philip Krause, deputy director of CBER’s Office of Vaccine Research & Review (OVRR), at the January 2018 WCBP sympos…