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.

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Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation

September 22, 2022: It is critically important that House and Senate committees work together to consolidate differences between the Food and Drug Amendments Act (H.R. 7667), which passed the House of Representatives on June 8, and the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348), which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 15.

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