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Policy Updates

"Precision Medicine" Proposal Includes $215M for NIH, FDA, ONC

President Obama’s “Precision Medicine Initiative,” which he unveiled on Jan. 30, will account for $215 million in his budget proposal. The funds will be divided between the National Institutes of Health (NIH), FDA and the Office of the National Coordinator for Health Information Technology (ONC), with the majority of the money being used for the development of a voluntary national research cohort.
» Read PMC's press release on the initiative
» Watch Obama's announcement of the initiative
» View the White House fact sheet

21st Century Cures Draft Tackles Device Review Pathways, Biomarkers
Among other topics, the U.S. House Energy & Commerce Committee's recently released "21st Century Cures" draft bill tackles innovative device review pathways and biomarker qualification.
» Access a summary of the bill

Senate HELP Committee White Paper Explores FDA, NIH Processes
The U.S. Senate Health, Education, Labor & Pensions (HELP) Committee's recent white paper explores how well FDA and the National Institutes of Health (NIH) processes support innovation.
» Download the white paper


PMC News

PMC Suggests Guidances on Risk, CLIA Accompany LDT Framework

In its response letter to FDA on the agency's proposed framework for regulating laboratory-developed tests (LDTs), PMC suggests that the agency publish draft guidance documents on risk classification and Clinical Laboratory Improvement Amendments (CLIA) harmonization alongside a second draft of the original framework documents.
» Download the Letter

PMC Joins Stakeholders for "Precision Medicine" Announcement
PMC's Amy Miller joined stakeholders at the White House on Jan. 30 when Obama announced his "Precision Medicine Initiative."
» Watch the announcement

PMC Engages 21st Century Cures
PMC advocates for additional draft guidance documents from FDA in this 21st Century Cures response letter.
» Download the letter

PMC Analysis: 20 Percent of 2014 Approvals Personalized Medicines
A PMC analysis of FDA's 2014 novel new drug approvals shows that more than 20 percent were personalized medicines.
» Download the analysis

PMC Summarizes 2014
In this blog post, PMC's Amy Miller reflects on 2014, which she calls "the year of the patient."
» Read the post