Search results for "FDA"
Article
Evaluating Design Margin, Edge of Failure and Process
FDA generally welcomes discussion on design space with applicants; discuss the design space and submission logic with FDA working groups as needed.
References
1. ICH, Q8 (R2) Pharmaceutical De…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
While a pathway has been in place since March 2010, a lack of guidance from FDA regarding specific requirements has created significant uncertainty for biosimilar manufacturers. That uncertainty was s…
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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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Elucidating Biosimilars Characterization
Quintiles: The amino-acid sequence of a biosimilar molecule is one of the starting points in determining similarity to the originator medicine, with the draft guidance from FDA implying that a biosimi…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
BIOSIMILARS
The FDA and European Medicines Agency (EMA) have indicated that the clinical testing requirements for a biosimilar drug can be reduced if it can be demonstrated that the biosimilar can…
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Quality by design for biotechnology products—part 1
US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
4. US FDA. Guidance for industry: PAT—A framework for innovative pharmaceutical …
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Maximum Output Starts with Optimized Upstream Processing
For instance, Regeneron has been working with FDA and the US government to rapidly scale up production of its REGEN-COV antibody cocktail. The company is leveraging production and manufacturing platfo…
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Reimagining Affordable Biosimilars
EMA regulations do not require animal immunogenicity studies, while FDA and several other regulatory agencies require preclinical results prior to initiating clinical trials (28).
Table II.…
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Tools and Processes for Mature and Emerging Therapies
Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) told the audience at an FDA Town Hall session that the agency is gearing up f…