This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.
We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”