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.
Websites, medical meetings, television talk shows, trade shows . . . wherever your products are being mentioned, chances are good the FDA is watching and looking for violations of the rules covering promotions. And with the agency cranking out three more social media guidances in 2014, you can expect even more challenges in the way the FDA evaluates promotions in the months ahead. Now’s the time to take stock of your promotional review practices and see if they’re really covering all the places they need to – even those you might least expect. And what you can do about it if they’re not.
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.