ACC Carefully Reviewing House Committee Proposal to Streamline FDA
This week, the House Energy and Commerce Committee released a 400 page draft of a proposal that would, if enacted, streamline the FDA's regulatory process, modernizing clinical trials and medical product regulation, and support the development of innovative cures.
The "21st Century Cures" discussion document is the result several months of hearings, including one at which ACC President Patrick T. O'Gara, MD, FACC, shared cardiology's perspective on personalized medicine.
The ACC is carefully reviewing the document and consulting with members to determine the strengths and weaknesses of proposals, especially those that might impact registries, cardiovascular devices or other cardiology-related items. The College is in close communication with Committee staff and will prepare comments on the draft, which is the first step in the legislative process. Input and grassroots advocacy from ACC members will be key as Congress moves forward.
Keywords: Individualized Medicine, Registries, United States Food and Drug Administration
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