The FDA’s new Breakthrough designation for new drug approvals

Courtesy of The Healthcare Channel, Dr. Janet Woodcock, the Director of the FDA’s drug division, CDER, discusses the newly created “Breakthrough” pathway for new drug applications. Distinct from Fast-track, a drug will receive a “Breakthrough” designation if, during early clinical trials, the drug shows significant efficacy for serious and life-threatening diseases. The new pathway could be a paradigm change for drugs in development to treat Alzheimer’s, ALS, and many other diseases.

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