Search results for "regulatory"
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Biopharma Takes a Nervous Glance Over Its Shoulder
Strong, science-based regulatory system.
FDA has long been viewed as the gold standard for a science-based regulatory system. However, the report says, the number and complexity of regulatory…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Smith also notes that the adoption of single-use manufacturing technology accelerates process validation and analytical testing for Novavax’s vaccines and may allow for ultimate regulatory approval of…
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Predicting Progress in Protein Aggregation
As a result, there is increasingly regulatory pressure for biopharmaceutical manufacturers to reduce the risk of immunogenicity by not only controlling, but also preventing, aggregate formation.
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Navigating Emerging Markets: Middle East and North Africa
Key Regulatory Considerations
Regulations vary considerably across the region. Turkey, for example, has introduced market exclusivity as part of its efforts to become a European Union (EU) m…
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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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Parenteral Drug Association
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded i…
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International Conference on Harmonization
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmace…
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Report from the 6th International HTPD Conference
…ws of mechanistic modeling, a live software demo, but also a deep dive into case studies, status of regulatory acceptance of modeling, and further fields of application.
Learn more about th…
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A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe …
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Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…