The industry is asking the FDA to pause enactment of guidance that would require manufacturers to report their progress on meeting quality metrics.

The FDA has nailed India's Indoco with a warning letter for a sterile and solid dose plant in Goa because of its concerns over an injected drug.

GlaxoSmithKline is recalling nearly 600,000 of its Ventolin inhalers in the U.S. after a defect was uncovered.

After a year of nothing but bad news about FDA citations of its plants, India’s Alkem Laboratories has announced something positive.

Mylan has expanded the recall of tens of thousands of potentially malfunctioning EpiPens to the U.S. and other markets throughout the world but says it has…

Mylan is recalling more than 4 million bottles of cholesterol fighter atorvastatin because some of the tablets might be contaminated.

The FDA scolded a Singapore maker of eye washes and other consumer products for poor manufacturing processes.

A recent FDA warning letter issued to Chinese API maker Jinan Jinda Pharmaceutical Chemistry says the company's efforts to fix issues are still not enough.

Drug Safety