Testimony, Briefings, Statements, & Reports

Testimony of Caitlin Kennedy, senior fellow, on nonthermal shortwave diathermy devices classification, FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Testimony of Caitlin Kennedy, senior fellow, on nonthermal shortwave diathermy devices classification, FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, on May 21, 2013 Read More >

Testimony of Dr. Jennifer Yttri on pedicle screw spinal systems FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Pedicle screw systems are used to stabilize the spines of patients who need spinal fusions to correct spine injuries, deformations, or degeneration. Dr. Yttri pointed out the lack of clear clinical evidence that pedicle screw systems are beneficial for patients and how the FDA should require clinical testing before approving new devices. Read More >

Comments to the FDA on “Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis”

The National Research Center for Women & Families and the TMJ Association oppose the reclassification of Temporary Mandibular Condyle prosthesis, a preamendments class III device, into class II. The proposed special controls are not rigorous enough to provide a reasonable assurance of the device’s safety and effectiveness. Read More >

Comments from Members of the Patient, Consumer, and Public Health Coalition Re: HELP Committee’s Draft Proposal on Pharmaceutical Compounding

The Patient, Consumer, and Public Health Coalition expressed concern that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. The Coalition provided comments on how to improve the draft to better protect the American public. Read More >

Testimony of Dr. Diana Zuckerman at the FDA meeting on Juvederm Voluma XC

Testimony on Juvederm Voluma XC FDA Advisory Committee on General and Plastic Surgery Devices, Caitlin Kennedy, Senior Fellow, May 2, 2013 Read More >

Testimony by Jennifer Yttri, PhD, senior fellow to the Oncology Advisory Committee of the FDA on tivozanib for kidney cancer

Dr. Jennifer Yttri testified at the FDA that more information is needed on the safety and benefits of the drug tivozanib before it should be considered for treatment of advanced kidney cancer. Read More >

NRC and Patient, Consumer, and Public Health Coalition comments to FDA: Don’t need a new pathway for limited populations!

The FDA considered a new way to approve drugs for use in small patient populations. NRC warn that such a pathway would put patients at risk of harm by giving them poorly studied drugs without knowing if the drugs provide any benefit. Read More >