An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

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 ...

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 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, ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...

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 ...