Comments on the FDA’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”

As members of the Patient, Consumer, and Public Health Coalition, we are pleased to have the opportunity to strongly support the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985). Continue reading

Comments on the FDA’s Draft Guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act”

As members of the Patient, Consumer, and Public Health Coalition, we conditionally support the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding. Continue reading

Public Comments on NIOSH Draft Intelligence on Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace

December 16, 2013. When notorious and decades-known carcinogens such as asbestos and radon are still present at unsafe or unknown levels in American workplaces, how can the public have confidence that our regulations can handle new and complex occupational hazards arising every day? Only a few hundred out of more than 80,000 chemicals in use in the United States have been tested for safety. We should be concerned. Continue reading

Testimony of Dr. Anna E. Mazzucco on Classification of Stair-climbing and Mechanical Wheelchairs

Stair-climbing wheelchairs are have been considered high risk – Class III – and have been required to submit studies of safety and effectiveness under the PMA review process. The proposed order being considered today would reclassify stair-climbing wheelchairs into Class II indicating moderate risk, and reviewing it through the 510(k) process. Continue reading

Comments on the NIH Office of Disease Prevention Strategic Plan for Fiscal Years 2014-2018

November 22, 2013. While improvement in public health measures can be more challenging to assess, and requires a longer time period to evaluate, the goal of prevention research should be focused on measurable health outcomes, and not simply on the number of grants or scientific publications. A more explicit identification and prioritization of research goals would increase confidence that meaningful public health results will be achieved where they are most urgently needed. Continue reading

Testimony of Dr. Anna E. Mazzucco on Premarket Approval of Nucleus Hybrid L24 System Cochlear Implants

My name is Dr. Anna Mazzucco, and I thank you for the opportunity to speak today on behalf of the National Research Center for Women and Families. After completing my Ph.D. in Cell and Developmental Biology from Harvard Medical School, I conducted research at the NIH. Those are the perspectives I bring today. Continue reading