November 20, 2013. We welcome the opportunity to comment on the FDA’s guidance to industry on preclinical detection of endocrine disruption potential in drug and biologics applications.
Read More »On Health Policy
Comments on FDA Safety and Innovation Act Section 907 Report
November 20, 2013. The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis.
Read More »Letter to FDA Regarding Advisory Committee Panel on Reclassification of CPR Devices
November 5, 2013. We write to express strong concerns about the September 11, 2013 FDA meeting of the Advisory Committee for Circulatory System Devices. This Advisory Committee meeting discussed and made recommendations regarding the proposed down-classification of External Cardiac Compressor (ECC) devices. The panel members were asked to consider the FDA recommendation that ECC devices be reclassified from Class III (high risk) to Class II (moderate risk) with special controls.
Read More »Patient, Consumer, and Public Health Coalition Comments on Requirements for Premarket Approval for Shortwave Diathermy for All Other Uses
October 4, 2013. We strongly support FDA’s proposed rule to classify the SWD for all other uses as a Class III device, which will require a PMA; we do not support a PDP for this device.
Read More »NCHR Testimony on Expanded Indications for Medtronic Cardiac Resynchronization Therapy Devices
October 8, 2013. We oppose the expansion of indications for Cardiac Resynchronization Therapy Devices. We urge FDA to require more testing to prove that the benefits of these devices outweigh the risks for these new indications in general and for particular demographic subgroups.
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