Search results for "FDA"
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
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Biopharma Takes a Nervous Glance Over Its Shoulder
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 requirements has increased, and executives are co…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The company received FDA approval for Flucelvax, the first cell-culture vaccine in the US designed to protect against seasonal influenza in individuals 18 years of age and older, in November 2012 and …
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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…
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Essentials in Quality Risk Management
FDA, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, 2004).
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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…
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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FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1).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 …