March 4, 2022: We write today to follow up on your response to several requests for information at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device User Fee Amendments (MDUFA V) stakeholders meeting on February 28, 2022.
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Aduhelm for the Treatment of Mild Alzheimer’s disease: Controversies and Policies
This article will provide an overview of the controversial drug Aduhelm (generic name aducanumab) that was approved by the Food and Drug Administration (FDA) as a treatment for Alzheimer’s disease for patients with mild cognitive impairment due to Alzheimer’s.
Read More »NCHR Comments on the Development of Non-Opioid Analgesics for Acute Pain
April 11, 2022. In light of the ongoing opioid epidemic, we commend FDA’s goal of fostering the development of non-addictive alternatives to opioids for managing acute pain, and thereby decreasing exposure to opioids and preventing new addiction.
Read More »FDA advisers to discuss ALS drug at Wednesday meeting
Politico, March 29, 2022. On March 30, FDA holds a highly anticipated advisory committee on neurological drugs to discuss a drug from Amylyx that aims to treat amyotrophic lateral sclerosis (ALS). Dr. Diana Zuckerman told Politico: “Did the FDA schedule an advisory committee meeting to placate patient advocates and other political pressure in the hope that the advisory committee would vote against it? Or is the FDA really considering approving it?”
Read More »Nonprofit Consumer and Public Health Organization’s Letter on MDUFA reauthorization to FDA and CDRH
February 22, 2022: We strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review.
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