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 a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

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 ...

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 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 ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

The term Secure Product Development Framework (SPDF) was introduced by FDA in the draft guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" ...