Next Steps for Patient-Centered Drug Development: Room for More Input, With Limits

Patient advocates are pushing FDA to take the next step in the agency’s patient-focused drug development initiative and more directly incorporate the patient experience into regulatory decisions. While that’s a welcomed ask, FDA officials say, it’s not as easy as it looks.

FDA Center for Drug Evaluation & Research Director Janet Woodcock admits that the agency has a lot to learn from patients about drug development and regulatory policy.

“We understand that people with chronic diseases are experts in that disease, as far as the symptoms and the impact on quality of life, and what might be acceptable trade-offs...

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