Germany's drug regulator has suspended the marketing of 54 medicines clinically tested by India's GVK Biosciences in compliance.
FDA and industry support global framework and collaborations to secure the supply chain.
Fake and shoddy medications kill about 100,000 people around the world each year. Many "drugs" are no more than just chalk or water. An engineer in Boston is trying to change that.
A lawsuit claiming that the largest pharmaceutical theft in U.S. history was an inside job at a shipper’s warehouse has been set for trial Oct. 9 in Miami.
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. FDA recently issued the final guidance "Allowable Excess Volume and Labeled Vial Fill SIze in Injectable Drug and Biological Products". This guidance clarifies the FDA regulatory requirements and ...
Guidance for Industry DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy The Drug Supply Chain Security Act (DSCSA) requires dispensers to comply with the new requirements related to product tracing beginning July 1, 2015. On this date, FDA officially issued ...
The European Union has accepted a recommendation to suspend hundreds of drugs that were authorized for use based on what regulators called “flawed” studies conducted by GVK Biosciences, a clinical research organization based in Hyderabad, India.
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This is why we need stronger sentencing guidelines!
SHANGHAI (AP) — This could be the story of an American dream. An immigrant family builds a successful business and buys a four-bedroom house in a quiet neighborhood with good schools for their young son. But not all is…
The US regulator has issued a warning letter to Sharon Bio-medicine for failing to pay generic drug user fee by its owner for three years.
A public awareness campaign has been launched in France to highlight the dangers of counterfeit medicines.