The US Food and Drug Administration (FDA) has issued draft guidance to assist sponsors in developing early-phase ...
The US FDA has unveiled draft guidance designed to assist rare disease therapy developers by providing regulatory clarity in developing personalized gene therapies. "Sponsors have sought clear FDA ...
The new draft guidance could enable more personalized treatments like the first-of-its-kind gene-editing therapy developed ...
In a final guidance issued on Monday, the US Food and Drug Administration (FDA) laid out its expectations for cell and gene therapy (CGT) sponsors to demonstrate that their products meet potency ...
On November 3, 2026, the United States Food and Drug Administration (FDA) finalized its December 2023 draft guidance Potency Assurance for ...
On July 13, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its guidance on “Psychedelic Drugs: Considerations for Clinical Investigations,” replacing the June 2023 draft ...
New FDA guidance clarifies potency assays for cell and gene therapy makers, easing development from early programs to IND ...
Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...
Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...
FDA final guidance sets a risk-based potency assurance roadmap for cell and gene therapies, spanning development, ...
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