Breast Implant Safety Alliance 10/31/24 Breast Implant Safety Alliance 10/31/24

BISA’s Recap of the FDA PEAC Meeting on Patient-Centered Informed Consent

It was encouraging to see the FDA gather expert opinions along with patient advocates and advisors to create improved guidance on more patient-centered informed consent materials for potential participants considering involvement in a clinical study. BISA compiled a few takeaways after the meeting.

Breast Implant Safety Alliance 10/16/24 Breast Implant Safety Alliance 10/16/24

FDA Patient Engagement Advisory Committee Meeting on Patient-Centered Informed Consent

The FDA welcomes participation during the October 30, 2024 Patient Engagement Advisory Committee (PEAC) meeting on patient-centered informed consent in clinical study of FDA-regulated medical products.

Breast Implant Safety Alliance 7/12/24 Breast Implant Safety Alliance 7/12/24

BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees

BISA worked improve the FDA’s Advisory Committee process by speaking at a recent listening session, along with a post-meeting with the Federation of American Scientists to discuss next steps.