The agency outlined the adjustments it's willing to make to "remove barriers and perceived misconceptions" for innovative medicines.
New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, including phased data submission to support earlier ...
Techne, bioMerieux, Roche, Lonza Group, Miltenyi Biotec India and More Cell and Gene Therapy Manufacturing QC Market Cell and Gene Therapy Manufacturing QC Market Dublin, Jan. 23, 2026 (GLOBE NEWSWIRE ...
In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications ...
The quality of a drug product is determined by the manufacturing line. Preclinical assessments and clinical trials provide an indication of safety and efficacy, but it is the manufacturing process ...
Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance.
SAN DIEGO--(BUSINESS WIRE)--Janux Therapeutics, a biopharmaceutical company developing novel T cell engager immunotherapies, today announced the appointment of Charles Winter as Senior Vice President ...
BOSTON and OXFORD, United Kingdom, June 07, 2021 (GLOBE NEWSWIRE) -- PepGen, Inc., a biotechnology company developing transformative oligonucleotide therapies for individuals living with neuromuscular ...
Flow Chemistry revolutionizes chemical synthesis, enhancing safety and efficiency in pharmaceuticals and sustainable manufacturing through continuous processes.
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