The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and ...

“A 25% tariff on Canada and Mexico threatens to upend the very supply chains that have made U.S. manufacturing more ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

Pain medication sold at Walmart is being recalled across the country due to an error that could have "fatal" consequences, the FDA says.

This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

Lay’s voluntary recall from December has been increased to the U.S. Food and Drug Administration’s highest risk level ...

Adragos Pharma, a global pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Munich, ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...

A previous FDA recall on certain Lay's potato chip products has now been updated to the category with the highest risk for ...