May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs.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 »On Medical Treatments & Products
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Read More »NCHR Comments on the FDA Draft Guidance Evaluating the Safety of Antimicrobial New Animal Drugs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.
Read More »Testimony of Diana Zuckerman on the Treatment of Duchenne Muscular Dystrophy before the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee
We testified at the May 2023 FDA Advisory Committee that Sarepta’s new treatment for Duchenne Muscular Dystrophy isn’t proven to work or to be safe, and that the company’s 3 previously approved DMD treatments are still not proven to work and have not submitted confirmatory trials as required.
Read More »