Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to

Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated.

The global wellness industry is doing superbly, thank you very much. In recent years, it grew a healthy 12.8 percent, becoming a $4.2 trillion market.

In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapi

These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S.

The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada.

The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand.

One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years.