Search results for "FDA" in Articles / App Notes
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Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
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Prepare for an FDA Bioburden Inspection
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.
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Prepare for an FDA Bioburden Inspection
A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help improve processes and procedures. Anastasia Lolas, former FDA …
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FDA Urged to Preserve Biosimilar Naming Conventions
In a letter to FDA, NCPDP cited operational problems with the implementation of a system other than the current INN system and stated concerns about what kind of impact that a change in system would h…
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A Look Ahead at BioPharma Manufacturing and Regulation
In October 2010, FDA issued a framework for advancing regulatory science for public health, which focused on the following: accelerating delivery of new medical treatments; improving pediatric and chi…
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Driving Improved Access to Biosimilars
In a formal statement in December 2018 (2), former FDA commissioner Scott Gottlieb referred to insulin prices, which have increased nearly 600% between 2001 and 2015, with the average US list price ri…
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Regulatory Challenges in the QbD Paradigm
It's no wonder that "Supply Chain Management," "Accountability in a Global Environment," "Foreign Inspections," and "International Compliance" were some of the key sessions at the 2011 PDA/ FDA Joint …
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Innovative Therapies Require Modern Manufacturing Systems
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and agency officials expect this pace to continue. Manufacturers are testing a full pipeline of importa…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA is considering at least three CAR-T applications, and more are on the way. An FDA advisory committee voted unanimously to recommend approval of Novartis’ new CAR-T, despite concerns about the firm…
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Biopharma Seeks Balance
To increase the potential for approval, companies need to provide better “packages” that describe how the drug works, said Scott Gottlieb, FDA commissioner, at the 2018 BIO convention in Boston on Jun…