Search results for "FDA" in Articles / App Notes
Article
The Metrics of Quality Culture
Schniepp
The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July 28, 2015. The official title of this guidance for industry is Request f…
Article
Understanding Validation and Technical Transfer, Part I
… Amendment to the US Federal Food, Drug, and Cosmetic Act, which among other provisions, authorized FDA to issue good manufacturing practice (GMP) regulations for “manufacturing, packaging, or holdin…
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Biosimilars to Drive Modern Manufacturing Approaches
FDA officials are emphasizing how advanced analytical methods can document product performance similar to a reference drug, and that cutting-edge technology can ensure reliable production of high-qual…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Sponsors gained important advice from FDA on conducting clinical trials during the pandemic from a steady stream of new guidance documents addressing the need for flexibility while maintaining study i…
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mAbs to Watch in 2016
Even before the product’s approval by FDA, BARDA granted Elusys its first delivery procurement order for Anthim so that the agency could add Anthim to its Strategic National Stockpile (SNS) as a count…
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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New Era for Generic Drugs
Former FDA officials recalled the challenges in establishing new policies for testing and evaluating generic medicines and how the program’s success has generated thousands of abbreviated new drug app…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
From the US perspective, there's a bunch of different guidelines on the FDA’s website you can look for, and you can also look on the European Union's website as well.
Looking at various Interna…
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Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…
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Challenges in Analytical Method Development and Validation
Technologies, such as FDA’s quality-by-design (QbD) initiative, may have a positive impact on analytical method development and validation according to Paul Smith, EMEAI laboratory compliance producti…