The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...

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 ...

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 ...

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 ...

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 An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...

The FDA’s Center for Drug Evaluation and Research has accepted the first letter of intent for an in silico drug development tool into the agency’s Innovative Science and Technology Approaches for New ...

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 ...

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