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…
Article
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
FDA, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, 2004).
Article
QbD and PAT in Upstream and Downstream Processing
…o 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 moni…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1). QTPP is defined in ICH Q8 (R2) as "a prospective …