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 ...

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

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

The integration of Artificial Intelligence (AI) in various sectors has been nothing short of transformative, and now, it’s poised to revolutionize the pharmaceutical industry. The U.S. Food and Drug ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...