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The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.
The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.
February 01, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
January 31, 2024
The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
January 24, 2024
Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.
January 19, 2024
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
January 18, 2024
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.