FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...
The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...
Dark Horse Consulting Group (“DHCG” or “the Group”), a leader in strategic and operational biotherapeutics consulting, and ...
EMA, African Medicines Agency, and African national regulators initiated joint oversight to accelerate Ebola clinical trials ...
The US Food and Drug Administration (FDA) has proposed guidance on the types of scientifically valid prior knowledge sponsors should consider when developing certain gene therapies (GT). The agency ...
Ariane De Ganck, Chief Scientific Officer at Ardena Scientific leadership for complex development.Ariane De Ganck, PhD, ...
Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...
The response identified specific Chemistry, Manufacturing and Controls (CMC) information requests and did not raise any ...
Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...
The US Food and Drug Administration (FDA) issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and ...
In the latest part of its plan to cut barriers to cell and gene therapy (CGT) development, the FDA has published draft ...
Amended IND clearance adds updated CMC elements (manufacturers, formulation, storage) and permits US enrollment for THIO-101 ...
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