BMJ, August 20, 2021: The FDA is being criticized for not holding an advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Will it undermine public confidence?
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NCHR’s Comments on Conveying Materials Information About Medical Devices to Patients
August 18, 2021. All information about materials should be listed in an understandable and accessible way for all devices – even tiny ones that are not the major focus of a surgical procedure – so that patients can make informed choices about their medical care.
Read More »NCHR’s Comment on Class I Surgeon’s and Patient Examination Gloves
May 17. 2021. We enthusiastically support the proposal to withdraw the January exemption for the Class 1 gloves noted above, returning the requirement for a report under section 510(k) of the FD&C Act.
Read More »Biden yet to nominate new FDA chief even as delta surges
The Hill, August 8, 2021: FDA news a new focus on public health that protects patient safety and ensures strong scientific evidence. We explain to The Hill that making the right choice is as important as making a decision soon.
Read More »7 things to know about bad COVID-19 tests
CBS 5, July 29, 2021: This CBS 5 investigation about FDA emergency use authorizations (EUAs) for COVID tests will shock you! Thanks to Kris Pickel, you can find out why so many COVID tests and antibody tests were not accurate and how many we still aren’t sure of.
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