The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...

In 2024, AI was one of the hottest topics, affecting every corner of nearly every industry. It has continued to become deeply ...

AI could deliver substantially greater efficiencies in cell and gene therapy manufacturing and enable more patients to ...

While Budget 2025 is expected to bring refinements that could further elevate certain industries, a critical shift in the ...

The industry is grappling with significant market shifts amidst emerging technologies and changing demands. Companies are now ...

Kolkata: The West Bengal health dept asked a saline manufacturing unit, which is a major supplier to govt hospitals, to stop manufacturing the product.

BatchMaster Software is proud to welcome Erawat Pharma, one of central India's most prestigious pharmaceutical manufacturers, ...

Today, Plantsulin blends this century-old discovery with modern scientific validation to offer a fast, convenient "whole-body reboot” for maintaining optimal glucose levels. Unlike restrictive diets ...

The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from ...

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...

National conference on pharmaceutical quality assurance and GMP guidelines with industry experts and government officials at AMTZ, Andhra Pradesh.