The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
The inability to conduct onsite inspections impeded investigators’ ability to uncover data integrity issues at manufacturing sites in drug warning letters in FY2021, underscoring the importance of ...
The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have ...
As part of a pilot program that launched in April, the agency is conducting shorter, focused screening assessments to ...
The U.S. Food and Drug Administration (FDA) published a draft guidance—the first of its kind—consolidating its expectations for how drug manufacturers should respond to Form 483 inspectional ...
WASHINGTON, D.C. (7News) — Thousands of miles away from the pharmacies we trust, Indian pharmaceutical companies produce the drugs that fill our medicine cabinets and hospitals. What happens inside ...
The primary market opportunities lie in equipping professionals with practical skills for preparing, managing, and responding to FDA inspections. This training addresses common challenges and ...
As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently gathered in Boston to discuss shifting regulatory paradigms under the Trump administration's ...
Ramakrishna Sesham, Senior Manager at Astellas Pharma, develops enterprise data governance frameworks that reduce FDA ...
USFDA concludes inspection at Zydus Biologics'' Ahmedabad injectable plant with 7 observations. No data integrity issues noted.
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