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 ...

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 ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

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The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing ...

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

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 ...

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and ...

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 ...