NCHR Testimony at FDA Advisory Panel on Wound Dressings

October 26, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on Wound Dressings. She pointed out that data on safety and effectiveness is lacking for these products even though they have been used for decades. Thousands of adverse event reports to FDA indicate contamination and problems with sterile packaging. FDA should classify them as Class III and require clinical trials and inspections.

Read More »

NCHR testifies for FDA Advisory Committee about withdrawing approval of Makena, to prevent preterm birth

October 17, 2022: In OB/GYN, preterm delivery is one of our most difficult challenges. The causes are complicated and not well-understood. But the associated harms are clear and devastating. We all want an effective intervention that will reduce the number of babies delivered too early and lead to better maternal and fetal outcomes. Unfortunately, current data do not indicate that Makena is the solution we have been seeking.

Read More »