The Regulatory Affairs Certification (RAC) is the leading credential for regulatory professionals in the healthcare sector. The two RAC designations are Pharmaceuticals (RAC-Drugs) and Medical Devices ...

Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The US Food ...

York, Pa., April 24, 2026 — MedCon 2026 convened this week at the Hyatt Regency Columbus in Columbus, Ohio, welcoming 224 attendees from eight countries and four continents for three days of ...

It isn’t always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug ...

The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for violations of current good manufacturing practices (CGMP) and for marketing ...

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...