Search results for " FDA" in Articles / App Notes
Article
Trends in BioPharma Approvals in 2013
Interestingly, FDA declined to approve the product last year, seeking additional cardiovascular outcome data.
Insulin degludec differs from native human insulin in that the threonine reside at pos…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilar…
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Prescribing Caution for Biosimilars
Briefly stated, these principals are:
•Substitution should occur only when FDA has designated a biologic product as interchangeable
•The prescribing physician should be able to designate a pre…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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QbD and PAT in Upstream and Downstream Processing
…to equipment design and implementation in biologic API manufacturing?
Girard (Spinnovation): FDA identified the use of new analytical methods, such as nuclear magnetic resonance (NMR), to mon…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…