November 5, 2009. Members of the Patient and Consumer Coalition urge your immediate attention to appropriately regulate tanning devices. As you know, currently, tanning devices are Class I devices (the same as bandages), which is the U.S. Food and Drug Administration’s (FDA) lowest risk device class and does not require comprehensive safety data.
Read More »On Health Policy
Letter to Principal Deputy Commissioner Sharfstein Expressing Concerns About the Food and Drug Administration Amendments Act (FDAAA)
October 6, 2009. In September 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law.
Read More »NCHR Comment on “Statement of Policy: Testing of Component Parts With Respect to Section 108 of the Consumer Product Safety Improvement Act”
September 16, 2009. Given that phthalate concentrations can be diluted in large toys, we agree with Commission staff that testing phthalate content as a percentage of the entire toy or child care article is less effective than testing materials and component parts that may contain phthalates.
Read More »NCHR Comment to the FDA on “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”
September 14, 2009. The National Research Center for Women & Families submits the following comments regarding the laser-assisted in situ keratomileusis (LASIK) and the post market experience associated with the use of LASIK devices.
Read More »NCHR Testimony to the FDA on Transparency
June 24, 2009. I have scrutinized FDA policies, processes, and decisions as a Congressional investigator and in my current position.
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