The Esophageal Cancer Action Network, a national nonprofit organization based in Baltimore, recently filed a citizen's petition with the U.S. Food and Drug Administration asking the agency to require warnings about the cancer risk of acid reflux on the labels of over-the-counter medications.

While labels on these over-the-counter medications currently warn people to get their doctors' recommendation before taking the medicine and warn against long-term use, they don't mention a cancer risk.

Continue Reading

Whether you're embarking on a computer system validation (CSV) or system remediation project, you'll likely need to navigate a quagmire of organizational, team, and human dynamics to come out successful at the other end.

Continue Reading

To Quality Assurance professionals in the pharmaceutical industry, Quality Risk Management (QRM) is a process attributed to a specific action: Assessing quality risks to a drug across its lifecycle.

But the value of QRM isn't pinned to a narrow set of product quality risks, nor does it have to be the long and arduous process it's often thought as. As an adaptable review framework, it can be applied in differing degrees to a number of situations where risk management plays a major role in the decision-making process.

Continue Reading