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biologics license application	21 cfr 601.41 requirements
fda guidelines for biologics	21 cfr 601.41 rating
fda surrogate endpoint	21 cfr 601.41 regulations
public health service act biologics	42 cfr
fda regulation for biologics	21 cfr 601.41 part
21 cfr for biologics	21 cfr 211
fda bla requirements	21 cfr 820
21 cfr 601.2 a	21 cfr 101