Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|March 15, 2020
- Pharmaceutical Technology-03-15-2020
- Volume 2020 eBook
- Issue 1
Inside FDA’s New Gene and Cell Therapy Guidances
Author(s)Agnes Shanley
In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.
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Since 2017, FDA has approved four gene therapies, and regulators expect the number of gene and cell therapies under development to increase dramatically.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 6–9
Citation
When referring to this article, please cite it as A. Shanley, “Inside FDA’s New Gene and Cell Therapy Guidances," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).
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Resources, Guidelines, and Guidance Documentsover 6 years ago
Regulatory and Standard Setting Organizationsover 6 years ago
A ‘New Normal’ for Quality?over 6 years ago
Monograph Development: Why and When to Participate (eBook)over 6 years ago
A Practical Approach to Pharmacopoeia Compliance (eBook)over 6 years ago
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