Business & Strategy

Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators For Immediate Release: April 10, 2020 The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 […]

COVID-19: European Commission recommendations on health systems resilience The COVID-19 pandemic puts enormous strain on healthcare systems. Most EU Member States have put in place measures to relieve pressure, therefore, helping in the diagnosis and treatment of the disease.

CONSULTING OPPORTUNITIES Do you have ten or more years of consulting experience in the pharmaceutical, biotechnology, or medical device industries? If so, E&E Medicals and Consulting wants to hear from you. Please send your CV and contact information to:info@eemedicals.com;  678-815-9233

FDA: Initiation of Voluntary Recalls From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft guidance, if finalized, would establish guidance for industry and […]

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 […]

The U.S. Food and Drug Administration (FDA) recognizes that the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities during the Coronavirus Disease 2019 (COVID-19) outbreak. On March 22, 2020, the FDA issued an immediately in effect guidance outlining a policy intended to help increase availability […]