Search results for " regulatory"
Article
EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
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FDA Seeks Metrics to Define Drug Quality
Predictive or forecast metrics include maintenance backlogs, complaint trends, internal audits, and the findings of regulatory inspections. Yield analysis or abnormalities of product per batch over ti…
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Essentials in Establishing and Using Design Space
Design space is proposed by the applicant and is subject to regulatory assessment and approval. Movement within the characterized design space is not considered as a change and, therefore, allows for …
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Advancing QbD in the EU
"But the regulatory adoption of the guidelines is clarifying what elements are considered essential to support the pharmaceutical development section of a marketing authorization application dossier."…
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Reviewing the Importance of Biosimilarity and Interchangeability
Data required for regulatory evaluation
Both biosimilarity studies and interchangeability studies provide information that is crucial for regulatory authority evaluation. Stamm emphasizes that ea…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
… procedures for how biopharma companies select, test, and manufacture medical products—and revised regulatory practices for evaluating clinical data, manufacturing operations, and procedures for subm…
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FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…
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Emerging Therapies Test Existing Bioanalytical Methods
PCR is a widely used platform; however, there is a lack of specific regulatory guidance and industry standards for development and validation. The Minimum Information for Publication of Quantitative R…
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A Plastic Pipeline for Commercial Bioprocessing?
Adoption for commercial production has been slow; however, as more therapies developed under single-use processes move toward regulatory approval, industry experts expect the percentage of biologic-ba…
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Navigating Data Integrity in the Modern Lab
The best way to ensure this consistency is by making it easier and less time-consuming to perform each routine activity, while passively recording each action for regulatory compliance. This can be ac…