ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

ADC Therapeutics seems to have run headlong into the FDA’s new strict policy on accelerated reviews: Get your confirmatory study in line before filing, or wait. The biotech’s biologics license ...

The Food and Drug Administration’s Dr. Robert Califf called on insurers Thursday to help ensure that studies on new drugs in the accelerated approval pathway are still completed. “I don’t think it’s ...