Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...

On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...

On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency’s authority to access and copy records related to cosmetic products under the Modernization of ...

Introduction to AuditsIn the fields of pharmaceuticals and medical devices where regulation is imposed, compliance with the quality standards set by the authorities is vital for the protection of the ...

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...

In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities is understaffing. The Food and Drug ...