Navigating the FDA approval process ranks among the most complex challenges facing manufacturers and distributors of ...

Shadow AI is already moving supplier specs, formulations, and traceability records off your control. What it means for FSMA ...

U.S. regulators are proposing a new rule that would require foreign tobacco manufacturers to register their facilities and list their products with the Food and Drug Administration, the same as ...

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 ...

Developing new medicines can require thousands of chemistry experiments to identify the right recipe for a safe, effective and ideally affordable drug. The process is slow and labor-intensive, and ...

The Katsina State Command of the National Drug Law Enforcement Agency (NDLEA) has intensified advocacy efforts to implement the newly introduced Drug Integrity Test (DIT) policy across tertiary ...

Michael Kaplan is an award-winning reporter and producer for the CBS News Investigative Unit. He specializes in securing scoops and crafting long-form television investigations. His work has appeared ...

The US Food and Drug Administration (FDA) recently sent warning letters to two facilities in the United States and Mexico for failing to comply with current good manufacturing practices (cGMPs) ...

Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and ...

May 29 (Reuters) - The U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's (DABU.NS), opens new tab plants following an ...