Topic: FDA warning letter
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.
Mylan on Tuesday acknowledged that the FDA had issued a warning letter for its troubled Morgantown, West Virginia, manufacturing plant.
The FDA's promo police issued their 7th official reprimand this year—and its third this month—to Vanda Pharmaceutical for webpage infractions.
The latest admonishment from the FDA's promo police is an unusual one. In it, the agency scolds an Eisai sales rep accused of misleading HCPs.
China fines vaccine scandal-hit Changsheng $1.3 billion; Merck and Samsung bail on a Lantus biosim; Taiho grows VC fund to sixfold.
The FDA OPDP slapped a warning letter on Mannkind for failing to mention Afrezza's risks.