FDA warns China’s Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or deceptive statements during an agency inspection of its manufacturing facility.
Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and use the input to resolve issues with the dashboard.
FDA warns China’s Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or deceptive statements during an agency inspection of its manufacturing facility.
Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and use the input to resolve issues with the dashboard.
FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.
FDA commissioner Marty Makary tells Fox Business that the agency will deploy its new “national priority voucher” program to significantly shorten drug review timelines for three psychedelic therapies at the center of president Trump’s executive order signed over the weekend.
