Factory Found in Ukraine Making Over 50 Counterfeit Medicines
Kyiv region – Officers of the Security Service of Ukraine dismantled a clandestine lab producing strong and toxic drugs. Half of counterfeit medicines, including known products – metandienone, nandrolone and testosterone, were smuggled, in particular to EU states.
Cargo thieves have used 3D printers to make fake security seals to hide when a shipment has been compromised.
Rx-360 Summary of Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for APIs http://p0.vresp.com/0RoSI2
Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients. On July 31, 2015, Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence ...
Rx-360 Summary of WHO Annex 5 Technical Supplemets http://p0.vresp.com/24FLOw
WHO Annex 5 Technical Supplements (to Technical Report Series 992) During The 137th World Health Organisation (WHO) Executive Board (EB) meeting, the Report of the 49th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations was presented.
Rx-360 Summary of EMA Draft Guideline on Manufacture of the Finished Dosage Form http://p0.vresp.com/1fmzB0
EMA Draft Guideline on Manufacture of the Finished Dosage Form. EMA has issued a draft guideline to clarify the type and level of information that should be included in the CTD Module 3 of the marking authorization application (MAA) dossier with respect to the manufacturing process description.
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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