一周药事法规更新(12Aug-16Aug)

微生物研究 2024-08-27 16:37:28

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20240812 视频回放│药审中心举办2024年第八期“药审云课堂”

https://www.cde.org.cn/main/news/viewInfoCommon/5ea44d6d2a17494dfb20acdccfaa1c46

2

国家药监局关于参苏感冒片等4种处方药转换为非处方药的公告(2024年第101号)

https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20240815150657149.html

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20240814 FDA approves axatilimab-csfr for chronic graft-versus-host disease

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axatilimab-csfr-chronic-graft-versus-host-disease

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20241815 FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-durvalumab-resectable-non-small-cell-lung-cancer

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20240815 FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-austrofood-and-continues-robust-activities-ensure-safety-cinnamon-products

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20240815 FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods

https://www.fda.gov/news-events/press-announcements/fda-announces-milestone-sodium-reduction-efforts-issues-draft-guidance-lower-target-levels-certain

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20240815 Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-voluntary-sodium-reduction-goals-edition-2

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20241816 FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis

https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis

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20240816 Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials

https://www.fda.gov/drugs/news-events-human-drugs/evaluating-negative-symptoms-schizophrenia-clinical-trials-08162024

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