The Latest

FDA Raises Concerns About China-Developed Drugs

U.S. regulators are poised to tap the brakes on approving dozens of cancer drugs and other new medicines developed in China.

Government Accountability Office: FDA Should Take Additional Steps to Improve Foreign Inspections

Recommends FDA develop tailored strategies and time frames to recruit and retain investigators for its foreign inspections.

Popular Drug Used to Treat Type 2 Diabetes Recalled Over Cancer-Causing Impurity

The FDA has announced the recall of one brand of a popular type 2 diabetes drug, metformin, over a potentially cancer-causing impurity.

Zydus recalls 4 lots of herpes injectable after complaints flag crystallization in vials

Fears about potentially deadly crystallization in herpes drug vials have spurred Zydus Cadila to yank four lots from the U.S. market.

30 years of Hatch-Waxman: Generic Drug Shortages and the Race to the Bottom

Reliance on foreign manufacturers, particularly those in China and India, has proven to be a major factor in causing shortages.

New Toxic Drug Impurities Detected in Some Heart Pills in U.S.

Officials urged drug recalls in 2018 but have yet to recommend action on latest impurity findings.

Drug Regulators Turn to Zoom-Style Plant Inspections During the Pandemic

With inspectors’ travel slowed, some nations are using head-mounted cameras and web conferencing to conduct foreign safety audits.

Indian pharmas account for over half of US FDA 'warning letters' this year

15 Indian companies received notices out of 32 warning letters issued by the U.S. FDA.