Pharma

The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated products. The accreditation is granted to third parties based on certain eligibility criteria and training. Manufacturers...

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...

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...

The FDA’s adverse event reporting system (FAERS) is a web-based tool that allows users to interactively search and query adverse event data. The tool intends to provide users access to adverse event reports submitted by the pharmaceutical industry, health care...

The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables...

January 12th is celebrated as National Pharmacist Day to recognize all the pharmacists across the nation. In addition to surgeons, nurses, and paramedics, this is another profession that contributes immensely to the health care industry. Historically, pharmacists only dispensed prescribed...

Uterine fibroids are a diagnosis that many women receive every day, however, it is a diagnosis that women often never hear of until they receive it. Uterine fibroids are defined as noncancerous growths of the uterus that occur during reproductive...

Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status.1 In most cases, the foreign regulatory body requires...