Search results for " guidance" in Articles / App Notes
Article
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In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…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The company’s efforts in manufacturing advancement were facilitated by the use of FDA’s recently-released draft guidance to industry titled, Advancement of Emerging Technology Applications to Moderniz…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Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…
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Ligand-Binding Assays and the Determination of Biosimilarity
FDA, in its May 2014 draft guidance on how to show biosimilarity using clinical pharmacological data, indicated that LBAs, concentration and activity assays, and PD assays were important for biosimila…
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Viral Clearance Challenges in Bioprocessing
Viral clearance is assessed in small-scale tests, and regulatory guidance documents provide a general framework for how these tests should be performed (1). Even with guidance, however, demonstrating …
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Continued Process Verification for Biopharma Manufacturing
FDA’s January 2011 process validation guidance emphasizes the need for companies to organize and use acquired knowledge and continually improve throughout the process lifecycle by making adaptations t…