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.
Read More »Author: Caroline Bradford
High Praise, Condemnation for CMS Aduhelm Coverage Plan
Medscape Medical News, February 16, 2022: Medicare has received a key endorsement and considerable support for its plan to restrict payment for the controversial Alzheimer’s disease drug aducanumab (Aduhelm) — but also drew pleas from other groups for more generous reimbursement of the drug.
Read More »Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee
February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.
Read More »Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research
October 28, 2021: NCHR comments on the proposed PDUFA VII Commitment Letter from the FDA.
Read More »Patient, Consumer, and Public Health Coalition Comment on CMS’s Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
February 10, 2022: As members of the Patient, Consumer, and Public Health Coalition, we strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population.
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