Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for Microgen Bioproducts’ Mercia Syphilis M kit due to higher level of non-specific cross-reactivity. This can lead to a false positive diagnosis of syphilis IgM, which was observed with lot nos. 052X1, 053X1 and 05411A.