Federal Register notice: FDA makes available a guidance on Technical Considerations for Additive Manufactured Medical Devices that is intended to prov...
Federal Register notice: FDA makes available a guidance entitled FDA Categorization of Investigational Device Exemption Devices to Assist the Centers ...
A Washington Legal Foundation online Legal Pulse praises FDA for again promoting uniform national regulation through appearances in several court case...
FDA releases its latest batch of Warning Letters that includes Hangzhou Facecare Cosmetics Co., Hand Biomechanics Lab, and PharmScript.
FDA approves an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizations in adults with e...
FDA approves Eli Lillys Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis.
Federal Register notice: FDA announces six modifications the agency is making to its FDA-Recognized Consensus Standards listing for use in premarket r...
FDA issues a new guidance on Technical Considerations for Additive Manufactured Medical Devices 3D Printing of Medical Devices that is intended to pre...