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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

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