Sandoz’s filgrastim could be a good test case as the company seeks FDA approval under the 351(k) abbreviated pathway.
From our Sept. 15 issue: To keep your cells “in character,” give them the right motivation (reprogramming), direction (transfection payload), and staging (culture conditions).
A new industry leader reigns supreme this year.
Check out these websites from GEN's Best of the Web.
Agency envisions a tiered approach—baseline regulations for all LDTs plus special requirements for riskier LDTs.
Novo Nordisk buys, retools NH plant for hemophilia API; ProBioGen sees double.
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