Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening...
Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
ADMA Biologics announced today (2/1) that the U.S. Food and Drug Administration (FDA) has granted approval for the ADMA BioCenters Plasma Collection Facility in Knoxville, Tennessee. Adam Grossman, President and Chief Executive Officer of ADMA, stated, “The approval...
One of the biggest areas of concern in the pharmaceutical industry, particularly in the United States, is the high costs of new treatments or drug therapies for patients. The recent initiatives from regulatory agencies like the Food and Drug Administration (FDA) to...
Translating for the life science sector is one of the fastest growing translation areas worldwide. Due to the global emphasis on innovation put on pharma and biotech companies, we see governments taking a closer look at policies and regulations. There is a pressure...
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