The Latest

Jan 16, 20221 min

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.

Dec 14, 20212 min

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.

Oct 20, 20211 min

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.

Oct 13, 20211 min

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.

Apr 13, 20211 min

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.

Nov 6, 20191 min

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.

May 31, 20191 min

Heritage Pharmaceuticals to pay $7 million to settle price-fixing allegations

The company, a subsidiary of India-based Emcure Pharmaceuticals, is accused of working with other generic drug makers to fix prices.