June 6, 2023: The U.S. Preventive Services Task force has changed its recommendations for mammography to start at age 40 instead of 50. However, they still recommend mammograms every 2 years instead of every year. We point out that there are racial differences in cancer risk and that mammography guidelines should reflect those racial differences. One size does not fit all.
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NCHR Comments on the FDA Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs. However, we recommended the FDA explicitly specify that studies need to have a majority of patients enrolled prior to receiving accelerated approval and that they advise against the use of single-armed trials.
Read More »NCHR Comments on AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management
May 19, 2023: NCHR commented on the AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management. Helping patients avoid opioids in the postoperative period may prevent pain conversion from acute to chronic pain, and also avoid opioid addiction. In order to achieve these two goals, opioid-sparing pain medications must be safe and effective in the postoperative period. Peripheral nerve blocks (PNB) have the potential to reduce perioperative opioid use and its associated adverse effects.
Read More »NCHR Comments on the FDA Draft Guidance Evaluating the Safety of Antimicrobial New Animal Drugs
May 19, 2023: NCHR supports the proposed criteria for ranking antimicrobial new animal drugs according to their importance to human medicine; however these criteria need to be applied correctly. FDA should classify bacitracin as medically important and should almost always give antibiotics belonging to the same drug class the same rankings of medical importance.
Read More »NCHR Comments on the FDA Filing of Color Additive Petition Concerning Red No. 3
May 18, 2023: NCHR strongly supports the petition from the Center for Science and the Public Interest urging an FDA ban on the use of FD&C Red No. 3 in foods, drugs, and dietary supplements. We find it unacceptable that the FDA has known for more than 30 years that Red 3 can cause cancer and yet still allows the dye to be used in these products.
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