Months after the FDA reported multiple violations at an Intas Pharmaceuticals plant in India and blocked imports, the agency shared more details Aug. 1, including a report of an analyst pouring acid ...

In a scathing rebuke (PDF) to AstraZeneca, the FDA cited “critical data quality issues that affect key analyses, including the primary endpoint” within a dataset for Saphnelo (anifrolumab) for the ...

The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...

Add Yahoo as a preferred source to see more of our stories on Google. Empower Pharmacy's facility at 7601 N. Sam Houston Pkwy. was the subject of an FDA inspection in November 2025, during which ...

The FDA is planning to only ask for one pivotal clinical trial instead of the long standard of two trials for drug approval. The present FDA commissioner believes it carries the same statistical power ...

The FDA sent another warning to an Intas Pharmaceuticals plant in India, where investigators imposed import bans in late 2022 after finding shredded quality control documents doused in acid. In early ...

Quality issues are still the number one reason for drug shortages, and in an effort to address this, the U.S. Food and Drug Administration is debuting a quality management maturity (QMM) program ...

Add Yahoo as a preferred source to see more of our stories on Google. The Food and Drug Administration has issued an order that bans Quality Poultry and Seafood from importing seafood, or any other ...

Recent articles have prompted questions about the quality of the nation's drug supply. Michael Kopcha, PhD, a registered pharmacist and the director of the Office of Pharmaceutical Quality at the FDA, ...

A quality control program for testing fluid milk and other dairy products at the Food and Drug Administration (FDA) has been suspended, according to reports, due to capacity issues following recent ...