Day: November 9, 2023

In the last 2 weeks, the FDA has recalled 26 over-the-counter (OTC) eye drop products sold at major pharmacies such as CVS, Rite-Aid, Target, Walmart, and others, all apparently linked to one manufacturer. The eye drops are suspected to be contaminated and their use poses a risk of infection in the eyes that could result … Read more

When the FDA refuses to issue export certificates for certain medical devices, the requesters can appeal the process. A new guidance document released this week describes the process for such appeals. Export certificates from the FDA are critical for manufacturers’ ability to export US-approved devices to other countries and any delay could have serious commercial … Read more