FDA issues a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip syringes.
FDA issues an online Frequently Asked Questions document on the shortage of sodium citrate blood specimen collection tubes used in coagulation testing...
FDA clears a Life Spine 510(k) for the ProLift micro Expandable Spacer System for endoscopic transforaminal and posterior lumbar interbody fusion proc...
FDA issues a Warning Letter to contract testing laboratory Missouri Analytical Laboratories after a May inspection cited significant GMP violations fo...
Federal Register notice: FDA announces a 10/26 Vaccines and Related Biological Products Advisory Committee meeting to review and discuss Pfizer-BioNTe...
FDA approves changes to the isotretinoin iPLEDGE REMS.
FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimers Disease.
FDA removes a Protagonist Therapeutics clinical hold on the company's rusfertide clinical tumor-detection studies.