Topic: FDA warning letter
The FDA has issued a warning letter to French drug testing lab Quali-Controle, saying some of its testing methods are unvalidated.
China FDA will take a new form; Celltrion's manufacturing issues might be worse than Teva hoped; Wuxi NextCODE and Google Cloud partner up.
The FDA issued a warning letter to Nan San Pharmaceutical for failing to conduct appropriate laboratory testing and marketing misbranded products.
Merck gets half of Lenvima's sales in $5.8 billion deal; Juno and WuXi's CAR-T JV got $90 million; FDA approved Taiwanese firm's HIV drug.
The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology, citing data integrity and product testing issues.
Shionogi’s flu drug won Japanese approval; Sun Pharma's Halol plant was cited by the FDA; EpimAb hired a top Novartis researcher as CMO; plus more.
An Indian drugmaker has halted production of a couple of APIs after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu, India.
The FDA's ad police have sent Collegium Pharmaceuticals their first letter of the year. And it tackles a hot-topic category: opioids.
After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.
A recently released FDA document shows that Pfizer's troubled fill-finish plant in Kansas was cited for continuing to repeat mistakes already cited by the FDA.