Laws, Regulations, Guidance, and Concept Papers

The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front.


Enforcement included two warning letters, one to a device firm and one to an OTC drug product manufacturer. Both are located outside the US. A handful of 483s issued to compounding pharmacies. No enforcement actions from Europe published this week. Recalls included those in Classes I through III. FDA posted two import alerts.

Among the product recalls were 64 products recalled by Sage Products. They received a warning letter in July regarding a lack of microbial control for their products as well as identification that their contract manufacturer shared drug manufacturing equipment with car wax and other potentially toxic products.