July 24, 2023: The FDA proposed a draft guidance on using generally accepted medical knowledge (GASK) when conducting nonclinical studies to help streamline product development, decrease costs, and hasten new product approval time. We do not recommend using GASK as the sole source of nonclinical data in new drug applications or biologic license applications as this could jeopardize the safety, toxicology, and efficacy of the product.
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NCHR Comments on FDA’s Bioequivalency for Generic Drug Formulations Draft Guidance
July 18, 2023: FDA draft guidance on bioequivalency is intended to streamline generic drug development and speed up patients’ access to generic medications. But some shortcuts that FDA proposes could result in unsafe generic medications that were not adequately tested. We highlight research standards that will help keep patients safe.
Read More »NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening
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.
Read More »NCHR Comments on the FDA Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs.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.
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