FDA officials are encouraging the pharmaceutical industry to switch from batch to continuous manufacturing, and they’re promising to help with the transition.
FDA Talks Up Continuous Manufacturing, Offers Assistance
It is time for drug makers to embrace continuous manufacturing methods, CDER Director Janet Woodcock and other FDA officials emphasize. Now the agency is offering additional support to help manufacturers move away from batch processes.
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US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
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