Search Results for 21st Century Cures Act

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Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation By Zachary Brennan - Published 16 May 2017

Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: 21st Century Cures Act, HHS budget, Trump budget cuts, OMB

BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices By Zachary Brennan - Published 15 May 2017

Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.

Categories: News, US, CDRH, Business and Leadership, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Roche Diagnostics, BD, Class II exemptions, 21st Century Cures Act

Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products By Robert D. Cumming, Nancy W. Mathewson, Esq - Published 14 April 2017

This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.

Categories: Features, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices

Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA

Law Firm Challenges FDA on Combination Product Appeals By Michael Mezher - Published 09 March 2017

Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Citizen Petition, Request for Designation, 21st Century Cures Act

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

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

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

BREAKING: Congress Seeks Dozens of Major Regulatory Reforms in New Bill By Alexander Gaffney, RAC - Published 27 January 2015

The US House of Representatives' Energy and Commerce (E&C) Committee today released a long-anticipated discussion draft of its 21st Century Cures Act, an ambitious attempt to overhaul the way the US Food and Drug Administration (FDA) regulates new healthcare products in the hopes of incentivizing the creation of new products to treat patients.

Categories: News, US, CBER, CDER, CDRH, Advertising and Promotion, Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Medical Devices, Orphan products, Submission and registration

Tags: 21st Century Cures Act, Congress, FDA Legislation, House, Energy and Commerce Committee