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Start Over You searched for: Subjects Biological Products -- therapeutic use Remove constraint Subjects: Biological Products -- therapeutic use Genre Technical Report Remove constraint Genre: Technical Report

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1. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

2. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

3. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

4. Betibeglogene autotemcel for beta thalassemia: effectiveness and value : final evidence report

5. A sense of déjà vu: the debate surrounding state biosimilar substitution laws

6. Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators