Search Results for 21st Century Cures Initiative

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Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill By Alexander Gaffney, RAC - Published 13 May 2015

An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Orphan products

Tags: Congress, 21st Century Cures Initiative, 21st Century Cures Act, Legislation, Bill, Energy and Commerce Committee, E&C

Congress Eyes Wider Use of Third-Party Medical Device Assessments By Alexander Gaffney, RAC - Published 13 May 2015

A revised version of the 21st Century Cures Act, a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems.

Categories: News, US, CDRH, Audit, Medical Devices, Quality

Tags: 21st Century Cures Act, 21st Century Cures Initiative, Congress, Bill, Legislation, Third-Party Audits, third-party quality system assessment

Regulatory Explainer: The (Updated) 21st Century Cures Act By Alexander Gaffney, RAC - Published 30 April 2015

The US House Energy and Commerce (E&C) Committee has released an updated draft of a piece of legislation which proposes dramatically overhauling the way in which the US Food and Drug Administration (FDA) regulates many healthcare products.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Explainer, 21st Century Cures Act, 21st Century Cures Initiative, Cures Act, House, Legislation, Congress

Legislation Overhauling Approval of Drugs, Devices Coming Next Week By Alexander Gaffney, RAC - Published 22 April 2015

Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act, a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products.

Categories: News, US, FDA

Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Legislation, Bill, Congress

Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation By Alexander Gaffney, RAC - Published 11 February 2015

The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: AdvaMed, Innovation Agenda, 21st Century Cures Act, 21st Century Cures Initiative

Senate Launches Bipartisan Effort to Assess, Change how FDA Regulates Medical Products By Alexander Gaffney, RAC - Published 03 February 2015

The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced.

Categories: News, US, FDA, Government affairs

Tags: Senate, HELP Committee, 21st Century Cures Initiative, Innovation for Healthier Americans, Legislation, 21st Century Cures Act

10 Proposals Worth Paying Attention to in the 21st Century Cures Act By Alexander Gaffney, RAC - Published 30 January 2015

Earlier this week, the House Energy and Commerce Committee released a draft of an ambitious new bill, the 21st Century Cures Act. The legislation, if enacted, would radically alter the way in which drugs and devices are regulated in the US. Within the 393-page legislation are dozens and dozens of proposals, large and small. But which ones are especially worth paying attention to? We're glad you asked. What follows is our analysis of which proposals are likely to attract the most attention—and controversy—in the coming months.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Congress, Legislation

As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition By Alexander Gaffney, RAC - Published 03 September 2014

Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups, including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Research and development, Submission and registration

Tags: LDT, Lab-Developed Tests, Laboratory-Developed Tests, 21st Century Cures Initiative, Congress, House, CDRH, Jeffery Shuren

Legislators Borrow From FDA's Approach in Seeking Patient Input About Regulatory Process By Alexander Gaffney, RAC - Published 19 May 2014

House legislators are quickly moving ahead with a new plan that hopes to overhaul how the US regulatory system reviews new medical products, and are now soliciting input from a group that has not traditionally been at the center of the regulatory process: patient advocacy groups.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: 21st Century Cures Initiative, Energy and Commerce, Patient Groups, Patient Advocacy Groups, Legislators

House Committee Unveils Intent to Overhaul FDA Regulatory Framework By Alexander Gaffney, RAC - Published 01 May 2014

Categories: US, FDA

Tags: Diana DeGette FDA, Fred Upton FDA, 21st Century Cures Initiative, House, Latest News, Congress, personalized medicine