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.
Allows retrieval of Import Alerts
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.
Yet another contract research organization in India is being scolded for its handling of clinical trial records.
Pharmacy group asks FDA to delay serialization to prevent supply chain disputations.
Nine people - including a pharmacist - have been arrested in Italy in relation to the sale of stolen pharmaceuticals.
News and updates from the MHRA Inspectorate
The U.S. Food and Drug Administration said on Thursday it had sent warning letters and seized potentially dangerous, unapproved medicines and medical devices from more than 1,050 websites