Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

From survivorship bias to root causes! Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

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 ...

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Business leaders must understand what patient-centric care really requires. Too often, patients, researchers and investors ...

A key part of consultants’ work is the global harmonization of CMC guidelines. Differences in regulatory requirements across regions can lead to inefficiencies in the drug development process.

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 ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...