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- FDA advises early engagement and error prevention for BLA submissions, says CBER expertA CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
- Indian government approves monitoring plan for adverse events in organ and tissue transplantation productsThe Indian government has given formal approval to a new program that will track adverse events linked to medicines and biologics used in organ and tissue transplantation. The initiative is design…