October 16, 2019. While there is a need for new antibiotics, those products need to have sufficient evidence of efficacy and safety. To continue to be the “gold standard” for approval, FDA needs to maintain high standards of evidence for approval.
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NCHR Comments on USPSTF’s Draft Recommendation Statement on Screening for Cognitive Impairment in Older Adults
October 7, 2019. We agree with the USPSTF draft that current evidence is insufficient to assess the balance of benefits and harms of wide-spread screening for cognitive impairment in older adults who do not have recognized signs or symptoms.
Read More »NCHR Testimony on Singulair and Neuropsychiatric Side Effects
September 27, 2019. Singulair has serious side effects and we need much better data to determine the likely benefit and risk of harm for patients. FDA has an important role to play in encouraging this research. In the meantime, patients, parents, and clinicians must be given clear information about the risks so that they can make an informed decision about whether to use montelukast (Singulair).
Read More »NCHR Comment on USPSTF’s Draft Recommendation Statement on Screening for Hepatitis C Infection
September 23, 2019. In general, we support the USPSTF draft recommendation related to HCV screening in adults; however, we are concerned about the potential for anxiety, stress, and other psychological harms for patients who are diagnosed with HCV but cannot afford to obtain treatment.
Read More »NCHR Testimony on Non-Prescription Nicotine Mouth Spray
September 18, 2019: This nicotine mouth spray has already been approved in several other countries, but that doesn’t mean that it is good product for the U.S. If we’ve learned anything from the Juul and vaping epidemic, it is that anything that delivers nicotine over the counter or online can be misused.
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