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
FDA has approved a bispecific antibody—Amgen’s Blincyto (blinatumomab)—for the treatment of refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blincyto targets cell surface proteins CD19 …
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The Bullish Outlook for Biosimilars
FDA is still developing its final regulations and guidelines pertaining to biosimilar approval in the US. While not formalized yet, preliminary guidance suggests that this pathway will require the com…
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Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…
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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…