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


4. 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


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


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