The Food and Drug Administration (FDA or we) is amending the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.

In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existen...

Background/introduction The U.S. Food and Drug Administration (FDA) has automatically classified focused ultrasound (FUS) devices Class III, which requires sponsors to demonstrate the safety and effectiveness of a device through clinical trials. This requirement adds significant time and cost to the device development process; reclassification to Class II would be highly beneficial for the futu...

Editor's Note: The following bulletin was published by the Food and Drug Administration (FDA) and posted on its Consumer Health Information Web site at http://www.fda.gov/consumer/updates/painmeds022309.html on February 23, 2009. We present it here because it is important for clinicians to know what their patients are being told by other authoritative sources.

Despite the lack of formal immunotoxicity testing guidelines, the assessment of immune function has been a routine component of toxicity testing for over twenty years. The European Agency for the Evaluation of Medicinal Products (EMEA) and The US Food and Drug Administration (FDA) have recently adopted new guidelines for immunotoxicity testing of new medicinal products. These two guidelines are...

UNLABELLED Bevacizumab is a recombinant humanized monoclonal antibody directed against vascular endothelial growth factor (VEGF). Though other VEGF inhibitors are being approved for the treatment of ophthalmological conditions, bevacizumab found its way into ophthalmology and clinical practice all around the world. The objective of this review is to present the ophthalmic dosage and administrat...

Submit Manuscript | http://medcraveonline.com Abbreviations: SB: Solvent-Based; Nab-Paclitaxel: AlbuminBound Paclitaxel; FDA: Food and Drug Administration; DHA: Dubai Health Authority; DH: Dubai Hospital; MTD: Maximum Tolerated Dose; AUC: Concentration-Time Curve; PFS: Progression-Free Survival; OS: Overall Survival; ORR: Objective Response Rate; ECOG: Eastern Cooperative Oncology Group; RECIST...

Abbreviations: LLOQ: Lower Limit of Quantification; QC: Quality Control; LQC: Low QC; MQC: Middle QC; HQC: High QC; SPE: Solid Phase Extraction; MRM: Multiple Reaction Monitoring; CV: Coefficient of Variation; RE: Relative Error; QqTOF: Quadrupole-QuadrupoleTime-Of-Flight; FDA: Food and Drug Administration; EMA: European Medicines Agency; XIC: Extracted-Ion Chromatogram; AUC: Area under the Cur...

The US Food and Drug Administration (FDA) approved the first oncolytic viral therapy (OVT), Imlygic (talimogene laherparepvec), in October 2015 for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery, although talimogene has not been shown to improve overall survival or have an effect on visceral metastases.

In this issue of Blood, Hong et al advocate for use of additional US Food and Drug Administration (FDA)–approved safety measures for transfusion. Most patients transfused with contaminated platelets do not show immediate clinical signs. Active surveillance suggests patient risk 10- to 40-fold higher than passive hemovigilance.