Search results for " guidance"
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Specifically, FDA outlines in the aforementioned guidance that protein aggregates elicit an immune response in humans through the following mechanisms: by causing B-cell activation as a result of cros…
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FDA Approves First Biosimilar
It was implied by speakers at the March 6 meeting that switching from one drug to another may be the focus of the forthcoming draft guidance on interchangeability. The formation of drug-specific antib…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…
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A Look Ahead at BioPharma Manufacturing and Regulation
Section 1124 of FDASIA calls for improving medical product decisionmaking through guidance documents and the adoption of tools, methods, and processes. The US Health and Human Services (HHS) Secretary…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Levine notes however that there are a few differences between the US guidance and the current EU regulations, some of which are favorable to developers of biosimilars in the US and some of which actua…
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Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
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Applying GMPs in Stages of Development
Can you provide some guidance on this point?
A. In today’s pharmaceutical environment, it is not uncommon for more than one company to be involved in the development of a product. V…
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FDA Framework Spurs Advanced Therapies
“The new guidance is a significant development that will enable us to work with our customers to improve patient access to novel cell and gene therapies,” observes Alison Keene, head of global regulat…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The company’s efforts in manufacturing advancement were facilitated by the use of FDA’s recently-released draft guidance to industry titled, Advancement of Emerging Technology Applications to Moderniz…
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Aseptic Processing: Keeping it Safe
Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…