Regulatory Roundup: European Medicines Agency Issues Drug Review Update; And More.
ePT--the Electronic Newsletter of Pharmaceutical Technology
European Medicines Agency Issues Drug Review Update; And More
The European Medicines Agency's Committee for Medical Products for Human Use issued an update on drug reviews by the agency on July 23, 2010. Included in the update is information on Avandia (rosiglitazone), generic drugs, pediatric indications, rotavirus vaccines, and more.
The US Food and Drug Administration issued a warning regarding certain Advair Diskus inhalers that were stolen from a distribution warehouse in 2009 and now have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be guaranteed and the inhalers should not be used, said the agency in its announcement.
Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025
March 17th 2025This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
