Failure of ALS drug puts a spotlight on controversial FDA approvals

Washington Post, March 16, 2024: New study results showing that the ALS drug Relyvrio does not work raises important questions about FDA’s decision to be flexible about approval even when the scientific evidence is lacking. We explain that the pendulum has swung too far and each questionable approval results in more pressure on FDA to make more questionable approvals.

Read More »

NCHR Comment on Classification of Certain Wound Dressings

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 »