Day: May 17, 2018

In a joint announcement, FDA and Office of Human Research Protection (OHRP) at NIH released a new guidance document today to address several deficiencies observed in the SOPs and other policy and practices documents maintained by IRBs. In all, FDA and OHRP listed 55 SOPs or written policies covering 5 major areas of compliance that … Read more

A Florida facility was found to manufacture pesticides and human pharmaceuticals using the same equipment leading to contamination of the drugs with pesticides as found by FDA auditors during a GMP inspection. The cardinal rule for GMP is “do no harm”, and the first place you control is contamination with unwanted ingredients. So it is … Read more