Search results for " review"
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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Regulatory Challenges in the QbD Paradigm
In this 28th article in the Elements of Biopharmaceutical Production series, the authors focus on the regulatory challenges that arise in the QbD paradigm, in particular on how review and inspection p…
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Assessing Manufacturing Process Robustness
This review process involves comprehensive process assessment (i.e., historical data review and the gathering of end-to-end manufacturing process data); extensive process monitoring and characterizati…
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New Era for Generic Drugs
The program expands FDA review staff, supports timely field inspections, and funds research on developing more complex generic dosage forms. One result is the elevation of the relatively small Office …
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Successfully Moving Regulated Data to the Cloud
Instead of the user and/or quality assurance reviewers needing to ‘hunt’ for deviations by looking at all of the data captured in a paper record, electronic systems can be configured to provide automa…
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Quality Systems Key to Lifecycle Drug Management
These developments reflect the struggle for regulators trying to review thousands of supplements, and for manufacturers implementing changes in products and manufacturing facilities around the world. …
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Modern Manufacturing Systems Key to FDA Quality Initiative
Quality data key
Science-based standards for application review and plant inspection support this approach by communicating clear expectations for industry. Such standards will aim to capture criti…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Stage 3: Criticality and continued process verification
At the conclusion of a successful PPQ, process validation activities move into an ongoing monitoring and review phase called continued proce…
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Innovative Therapies Require Modern Manufacturing Systems
And the legislators extended the rare pediatric disease priority review voucher program until September 2016 to keep it going until Congress can review and reauthorize it.
Manufacturing concerns
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Breakthrough Drugs Raise Development and Production Challenges
Expert review teams in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are meeting deadlines and goals for assessing breakthrough designa…