The US Food and Drug Administration (FDA) on Thursday finalized its guidance on the use of alternative tools for conducting preapproval inspections (PAI) or prelicense inspections (PLIs) in lieu of ...

FDA finalized guidance setting out how drug sponsors should label, describe and submit content from software used alongside ...

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA ...

The scope covers prescription drugs and drug-led, drug-device combination products where the Center for Drug Evaluation and ...

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance is intended for ...

The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...

FDA inspections of drug manufacturing facilities are far below their pre-pandemic numbers. The agency says that it is now hiring more inspectors than it is losing but inspection numbers are still ...

WASHINGTON, DC - APRIL 22: Food and Drug Administration Commissioner Marty Makary speaks during a news conference at the Health and Human Services Department on April 22, 2025 in Washington, DC.