Search results for " FDA" in Articles / App Notes
Article
Sterilization Trends for Single-Use Consumables
The driver behind this trend stems back to a Form 483 issued by FDA (4) indicating that the pharmaceutical manufacturer may not have understood or challenged the statement on a supplier certificate st…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Biosimilars and the impact of FDA guidance
BioPharm: Regarding biosimilars, there have been some changes in the US, with FDA setting requirements for analytics and for interchangeability…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Yu, deputy director of the Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research, talked about the future of pharmaceutical quality—and the challenges of achieving quality …
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Microbiological Testing: Time is of the Essence
In addition, FDA has made changes to its microbial testing requirements that have had a positive impact on the development of more rapid, advanced microbiological methods (2). Amendments to the Steril…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The methods are well suited for routine use in the quality-control environment and the provided identification approach meets CFR, FDA, and other regulatory agencies requirements. As part of this appr…
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Biopharma in 2015: A Year for Approvals and Innovations
One of the most groundbreaking approvals occurred in March, when the FDA approved the first biosimilar in the US (years after the first such approval in Europe), Sandoz’s Zarxio (filgrastim-sndz). The…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
To support this process, regulatory authorities such as FDA and the European Medicines Agency have issued guidelines aimed at securing safety and efficacy of biotherapeutic medicines. Antibodies, cyto…
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The Bullish Outlook for Biosimilars
Unique to the US, FDA will designate these follow-on biologics as either ‘biosimilar’ or ‘interchangeable biosimilar’ based on the level of evidence submitted. While there is still plenty of uncertain…
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Quality by Design and Extractable and Leachable Testing
The FDA guideline states that CQAs are generally associated with drug substances, excipients, intermediates, and drug product, but the concept can also be applied to container closure systems. While i…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…