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Biosimilar developers can expect the FDA to demand costly clinical trials to verify that a biosimilar is effectively identical with a reference product. Read More
Drugmakers need to better connect their clinical and R&D operations to cope with the growing cost and complexity of clinical trials amidst declining drug approvals. Read More
A law firm that represents drugmakers is urging the FDA to rethink its stance on granting meetings with senior agency officials, saying the existing policy can imperil drug research. Read More