NCHR supports the proposed FDA rule, which aims to reclassify wound dressings and liquid wound washes containing antimicrobials based on their level of antimicrobial resistance (AMR), with higher-risk products categorized as Class III. This change is crucial for mitigating the public health threat posed by AMR, ensuring the appropriate use of these medical devices, and ultimately improving patient outcomes.
Read More »Author: Caroline Bradford
Why journalists should scrutinize the FDA’s accelerated drug approval process
Healthjournalism.org, March 7, 2024 article by Association of Health Care Journalists explains the problems with the FDA accelerated approval process and gives advice on how to cover the evidence accurately. NCHR’s Diana Zuckerman explains that when FDA rescinded approval of the cancer drug Pepaxto, it was an easy call because the company took it off the market 2 years ago because of the higher death rate in a clinical trial.
Read More »Statement of Dr. Diana Zuckerman on Behalf of the National Center for Health Research FDA Advisory Committee Meeting on AMX0035 for ALS
September 7, 2022 Diana Zuckerman testified on behalf of NCHR at the FDA Advisory Committee hearing about the poor evidence foe Amylyx drug AMX0035 for the treatment of ALS, and how approving this drug would undermine other ALS clinical trials that are underway.
Read More »Accelerated Approval Withdrawal Offers Hints On New FDA Approach
Inside Health Policy, March 4, 2024: NCHR was interviewed regarding the FDA rescinding accelerated approval for Pepaxto for multiple myeloma. We explain that the FDA’s new “’streamlined’ path to reverse approval decisions still takes years even after there is proof that patients taking the drug are more likely to die.
Read More »NCHR Testimony in Support of HB1147 for the Maryland House of Delegates Environment and Transportation Committee
February 28, 2024: NCHR provided written testimony to the Maryland House of Delegates Environment and Transportation Committee in support of HB1147, a bill to prohibit the sale and installation of playground surfaces that contain levels of lead, PFAS, or PAH chemicals.
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