Day: January 11, 2018

FDA released a new guidance to describe the current process for arranging meetings with the review divisions in CDER ad CBER combining and simplifying information from previous guidance documents, updating some critical timelines and retiring the old defunct guidance documents on the same topic. In the last decade, FDA’s management carried out a major publicity … Read more

Last year FDA conducted 17,487 audits worldwide, and issued 5045 FDA 483s, meaning that about 30% of the audits lead to non-compliance in more than one regulated area. There were 498 Warning Letters issues during the same time showing that 1 in 10 audits found repeat violations that required more serious enforcement action by FDA. … Read more