India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.

An examination of the trade secret risks posed by the integration of generative AI (GenAI) and agentic AI into core business ...

The FDA has flagged three third-party labs that submitted device testing data that may have falsified, invalid or copied from ...

For the review to withstand the necessary scrutiny it will face upon publication, the FDA must prioritize robust, real-world data sources.

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...

This voice experience is generated by AI. Learn more. This voice experience is generated by AI. Learn more. “If the Medication Affordability and Patent Integrity Act passes,” says health expert Sally ...

The National Drug Law Enforcement Agency (NDLEA ), Katsina State Command, has championed integrity tours and advocacy on tertiary institutions, for the new Drug Integrity Test (DIT) policy across ...

The U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's plants following an inspection earlier this year, according to an ...

The Food and Drug Administration approved a treatment from Ionis Pharmaceuticals to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia. The FDA said the ...

Novartis has reported a phase 1/2 win for one of the jewels of its $12 billion Avidity Biosciences buyout, setting the Swiss drugmaker up to talk to global regulatory agencies about the next steps for ...