Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...
When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...
PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth ...
The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI)[1] models in drug development and in regulatory submissions titled, ...
The Food and Drug Administration (FDA) published a pair of discussion papers this week in an effort to outline areas artificial intelligence and machine learning may help in manufacturing ...
Nurix Therapeutics has had a phase 1 trial of its B-cell malignancy drug put on partial hold by the FDA while the biotech revamps its manufacturing process. The hold follows the company alerting the ...
Creating medical technology products brings with it high risks and cost but can also generate huge rewards. Medical product development combines the challenges of creating systems with ...
ScinoPharm receives US FDA approval for glatiramer acetate injection to treat multiple sclerosis: Taiwan Tuesday, January 6, 2026, 14:00 Hrs [IST] ScinoPharm Taiwan, a professiona ...
Recursion Pharmaceuticals leverages AI and machine learning to revolutionize drug discovery, reducing costs and accelerating development, positioning itself as a leader in tech-driven biopharma. The ...
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