October 14, 2014. We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention.
Read More »On Health Policy
NCHR Testimony at FDA Advisory Panel on Device Classification
Oct. 9, 2014. NCHR supports the FDA’s recommendation that More-than-Minimally Manipulated (MMM) Allograft Heart Valves be classified as Class 3 devices and therefore subject to the premarket approval process. All other types of heart valves under the oversight of the Center for Devices and Radiological Health at the FDA are classified as class 3. There is no reason that these heart valves should be an exception.
Read More »Comments on Intent to Exempt Certain Medical Devices From Premarket Notification Requirements
October 6, 2014. We strongly urge the FDA to reassess the Submission Type for the above devices and continue to require 510(K) clearance due to the high number of MAUDE reports, including numerous deaths from these devices. Devices that can cause fatal adverse events should not be exempt from FDA regulation.
Read More »Presentation at the 2014 Congressional Black Caucus Fall Health Braintrust
September 26, 2014. Senior Fellow Laurén A. Doamekpor, Ph.D., M.P.H, gave a presentation titled “Racial/Ethnic Diversity in Clinical Trials: Implications for Black Women’s Health” at the 2014 Congressional Black Caucus Fall Health Braintrust.
Read More »NCHR Testimony at the FDA Joint Meeting for Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
September 17, 2014. From 2010 to 2013, the number of patients receiving testosterone prescriptions increased from 1.3 million to 2.3 million. That means a large and growing number of patients may be at-risk for major adverse events due to TRT. At the same time, it is not clear what percentage of the men taking TRT actually need it for medical reasons.
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