Search results for "qbd"
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Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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Guidance for Industry: Quality Considerations in Demonstrating Protein Product
FDA's guidance for Industry Quality Considerations in Demonstrating Protein Product
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EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.
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PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
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Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom's government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. T…
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State Food and Drug Administration, P.R. of China
China's regulatory organization overseeing drugs, medical devices, health food and cosmetics, as well as food safety .
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FDA Guidance Documents
A searchable database of FDA guidance documents