Month: April 2020

Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic. In […]

Best Portable Oxygen Concentrators To Buy 2020 Best Portable Oxygen Concentrators To Buy 2020 by Rebecca Black Portable oxygen concentrators or POCs represent medical grade breathing devices aimed at patients with sleep apnea or other breathing-related conditions. Once, oxygen concentrators used to be heavy, difficult to use and they would allow minimum freedom of movement. Today, portable […]

For Immediate Release: March 28, 2020 Statement From: Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D. During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products. The agency is continuously examining the global supply chain to […]

Do you know the material and format specifications for Non-clinical Bench Performance Testing Premarket Submissions? The latest FDA guidance specifies the relevant information to be included in a premarket submission, summaries, study protocols and full test report for non-clinical bench testing.   Such submissions include premarket approvals (PMA), humanitarian exemption system (HDE) applications, premarket notification (510(k)) submissions, IDE […]