Topic: FDA warning letter
Drug wholesaler McKesson was lashed in an FDA warning letter for shipments in which opioids had been replaced by OTC drugs.
Takeda pulls an FDA filing for Ninlaro and is ordered to pay $155 million in a Shire patent case; a cancer startup gets Chinese investors' attention.
The FDA in 2017 ripped Indian drugmaker Lupin’s Indore plant for repeating mistakes. In a new visit, the FDA has again found problems.
The American Hospital Association has crafted a lengthy list of suggestions for addressing drug shortages that include both the carrot and the stick.
FDA slaps Akorn with warning letter following an inspection of its sterile injectables plant in Illinois.
India scrutinizes whistleblower case against Sun; FDA slaps warning letter on valsartan API maker; Eisai and UCL push anti-tau drug into the clinic.
The most recent inspection of Pfizer's troubled injectables plant in McPherson, Kansas, found eight observations, seven of them repeats.
The Chinese API maker at the heart of a global scare and recall of blood pressure medicines has been savaged in an FDA warning letter.
Tris Pharma, which was slapped this year with a warning letter, is recalling three lots of an infants' pain reliever it says could be harmful.
Mylan has expanded its valsartan recall to all lots; a Japanese company is buying a Boehringer Ingelheim API plant, plus more manufacturing news.