On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency’s authority to access ...

Government shutdowns lead to decreased predictability, causing delays in new submissions and manufacturing changes. Key risk ...

In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

Add Yahoo as a preferred source to see more of our stories on Google. Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of ...

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. U.S. inspectors have uncovered new and dangerous ...

We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of the factories that made them.

An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...

With every bottle of prescription medication comes an implied promise: The drugs are safe and effective and meet strict standards set by the Food and Drug Administration. But the agency known as one ...