The FDA has issued a show-cause notice to Hindustan Antibiotics Limited over serious manufacturing lapses and halted ...

After submitting its timed-release version of a decades-old ADHD drug to the FDA nearly a year ago, Kansas City's Cingulate ...

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 U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing ...

The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and point-of-care (POC) ...

The FDA PreCheck program, first announced in August, aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary ‌regulatory requirements, in line with ⁠President Donald ...

India-based Malladi Drugs & Pharmaceuticals and Labocont Industrial SRL’s drug manufacturing facility in the Dominican Republic drew US Food and Drug Administration (FDA) warning letters over failures ...

Aug. 7 (UPI) --The U.S. Food and Drug Administration announced Thursday it is launching the "FDA PreCheck" program in order to help construct drug manufacturing sites in the United States. "Our ...

At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising ...

By Sruthi Narasimha Chari and Christy Santhosh June 11 (Reuters) - Wall Street has pushed to next year expectations for a U.S ...

The FDA began accepting requests Feb. 1 to participate in its PreCheck pilot program, an initiative aimed at streamlining regulatory review for new U.S.-based pharmaceutical manufacturing facilities.