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- Manufacturing Consideration for Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
- FDA Reissues EUA Guidance for use of COVID-19 Convalescent Plasma
- Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers
- Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
- Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics