FDA

On April 2nd, 2021, the FDA provided an update on its Pandemic Preparedness and Recovery Plan (PREPP) Initiative. The initiative evaluated FDA’s response to the pandemic by an independent third-party reviewing agency that published a summary report outlining recommendations for...

Public health is generally defined as the health of the population as a whole. The World Health Organization gives a more detailed definition as “the art and science of preventing disease, prolonging life, and promoting health through the organized efforts...

Every year April 7th is celebrated around the world as World Health Day. Never has this day been more important than it is right now. As many are wishing for the day that life is back to normal or the...

As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve public health each day is more important than ever. The American Public Health Association celebrates the week of April 5th- April...

NIST stands for National Institute of Standards and Technology and this federal agency develops and promotes measurements, standards, and technology to improve system productivity. NIST has a robust Cybersecurity Framework and is one of the most popular topics in the...

Cell therapies are regulated as biologics under the Center for Biologics Evaluation and Research division of the FDA. All somatic cell therapies are regulated as biologics, however, some of the human cell therapy products are not considered biologics because of...

March 30 is celebrated every year as National Doctors Day. This day is in honor of the physicians who devote their lives and careers to caring for the health and well-being of their fellow citizens. At EMMA International we can...

Medical devices are made to save lives; but what happens if these devices cause more harm than good? There can be varying consequences, typically dependent upon the size of the organization. If there is a life-threatening or serious issue with...

Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both...

One of the major purposes manufacturers incorporate AI or ML in their applications is to ease software computations and to predict precise results. I think compared to any other application, a medical application requires a lot of precise computations and...