Newsletter - May 18, 2018
No You Cannot Manufacture Pesticides and Drugs with the Same Machine.
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. Read More
FDA Wants IRBs to Write Better SOPs
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. Read more
No You Cannot Manufacture Pesticides and Drugs with the Same Machine.
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. Read More
FDA Wants IRBs to Write Better SOPs
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. Read more
