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EROD70 on Twits posted Bero Sakigake coming 10/30https://pj.jiho.jp/article/243039 REGULATORY Sakigake-Designated HAE Med Berotralstat, AZ’s Acalabrutinib Up for PAFSC Review on Oct. 302.3 PAFSC consultation After the PMDA review, the PAFSC is then consulted for discussions by the related committees and the Pharmaceutical Affairs Committee as required on the basis of the review report. After the PAFSC report is obtained and it is confirmed that the standards are met in a separate GMP compliance review, the Minister grants the new drug manufacturing/marketing approval. |
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