George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

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) on Thursday announced FDA PreCheck, a program developed in response to a recent executive order signed by President Donald Trump to encourage domestic drug ...

Billions of prescriptions for generic drugs are filled in the U.S. annually. The FDA tests only a few dozen of them every ...

A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the FDA’s crosshairs for the second time in less than a year. The FDA has ...

Today, ProPublica is launching Rx Inspector, a first-of-its-kind database that provides answers to what the FDA won’t tell us: where our generics are coming from and the track records of the factories ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...

Drugs currently shortage FDA total 75 as of Dec. 30, down from 194 in June, mainly hospital injectables and acute care meds.

The approval marks the first new pharmacologic treatment in motion sickness in over four decades. The US Food and Drug ...