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USFDA Guidance: CMC Flexibilities to Accelerate Human Cellular and Gene Therapy Development
Human cellular and gene therapy (CGT) products are transforming modern medicine by offering innovative treatments for serious and life-threatening diseases such as cancer, genetic disorders, and chronic illnesses. However, the development and manufacturing of these therapies are often highly complex due to personalized production processes, advanced technologies, limited patient populations, and short product shelf-lives. To support innovation while maintaining product qualit
Sharan Murugan
May 104 min read
USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and...
Sharan Murugan
May 1, 20242 min read