The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release ...

Over 11,000 bottles are being pulled from shelves after testing revealed a manufacturing error that introduced trace amounts ...

The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...

A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. have landed in the FDA’s crosshairs thanks to quality shortfalls, poor testing standards ...

The status could support staged transitions to new manufacturing processes, potentially mitigating some risks of high-stakes ...

The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to ...

More than 34 million Americans take blood pressure medication every day, according to the Centers for Disease Control and ...

Billionaire Mark Cuban has urged the Trump administration to waive the hundreds of thousands of dollars in regulatory fees ...

PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) approved a state-of-the-art drug product manufacturing hub in Parsippany, NJ, for ...

Quality control errors during pharmaceutical manufacturing are unfortunately common occurrences. The majority (around 50%) of employees that work in pharmaceutical manufacturing tend to have duties ...

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products ...

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05%, which ...