Pharmaceuticals

If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it going back and just simply fixing non-compliances, is it a response to regulatory enforcement actions? The short answer is...

World Cancer Day, established by the Union for International Cancer Control (UICC) in 2000, is observed every year on February 4th. Over 10 million people die each year from cancer, more than HIV/AIDS, malaria, and tuberculosis combined.1 This makes cancer a...

February 3rd is celebrated as National Women Physicians Day. This day marks the birthday of Dr. Elizabeth Blackwell, the first woman to receive a medical degree in the United States in 1849. The day is celebrated in recognition of female...

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...

COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have received their first dose of the vaccine.1 This is excellent news, but you may be wondering what the next step...

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...