Search Results for FDARA

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Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses By Zachary Brennan - Published 29 September 2017

Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices intended to be permanently implantable, life-sustaining or life-supporting.

Categories: News, US, FDA, Medical Devices

Tags: third-party review of medical devices, FDARA, implantable devices

FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements By Zachary Brennan - Published 12 September 2017

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Categories: News, US, FDA, Clinical, Drugs

Tags: FDARA, PREA, pediatric clinical trials

FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II By Zachary Brennan - Published 22 August 2017

Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: FDARA, GDUFA, pre-submission guidance

Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022 By Zachary Brennan - Published 21 August 2017

President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDARA, FDA user fees, user fee reauthorization, medical product reviews

House Passes Bill to Reauthorize FDA User Fee Programs By Zachary Brennan - Published 12 July 2017

In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

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

Tags: FDARA, FDA user fee reauthorization, user fees, BsUFA, MDUFA, GDUFA, PDUFA

Tight Timeline to Reauthorize FDA User Fee Programs Before FDA Begins Layoffs By Zachary Brennan - Published 29 June 2017

The US Senate and House of Representatives have given themselves a little more than 10 working days to finish a bill to reauthorize the US Food and Drug Administration (FDA) user fee programs and get it signed by President Donald Trump before thousands of FDA employees will receive layoff notices.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDARA, user fee reauthorization, FDA user fees, user fee deals

User Fee Reauthorization Bill Advances in the House By Michael Mezher - Published 07 June 2017

The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House.

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

Tags: User fees, Reauthorization, FDARA

Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge By Alexander Gaffney - Published 04 June 2012

Categories: FDA

Tags: CREW, FDARA, Public Citizen, Letter, POGO, House, Transparency, Latest News

Congressional Research Service Releases Side-by-side Analysis of User Fee Bills By Alexander Gaffney - Published 01 June 2012

Tags: Side-by-Side, CRS, FDARA, FDASIA, User Fee, MDUFA, analysis, Latest News, GDUFA, PDUFA

House Overwhelmingly Passes User Fee Legislation By Alexander Gaffney - Published 31 May 2012

Tags: Approve, Amendments, FDARA, FDASIA, Vote, House, User Fee, MDUFA, Latest News, GDUFA, PDUFA

House Version of user Fee Legislation Gets Major Boost from CBO By Alexander Gaffney - Published 30 May 2012

Categories: FDA

Tags: PAYGO, Pay-as-you-go, FDARA, CBO, FDASIA, Budget, Scoring, Latest News

Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill By Alexander Gaffney - Published 30 May 2012

Tags: Lidoderm, Bioequivalency, FDARA, Endo Pharmaceuticals, Bioavailability, Competition, Generic, Latest News, GDUFA, PDUFA

House to Vote on User Fee Reauthorization, Medical Device Tax Repeal Bills By Alexander Gaffney - Published 29 May 2012

Categories: FDA

Tags: FDARA, Vote, Energy and Commerce Committee, User Fees, Legislation, House, MDUFA, Latest News, Congress, PDUFA

Senate Easily Clears Amended User Fee Bill By Alexander Gaffney - Published 25 May 2012

Categories: FDA

Tags: FDARA, CBO, FDASIA, House, User Fee, MDUFA, Latest News, Senate, Congress, GDUFA, PDUFA

White House Throws Support Behind Senate User Fee Bill By Alexander Gaffney - Published 17 May 2012

Tags: Support, FDARA, FDASIA, OMB, User Fee, MDUFA, Latest News, Senate, Obama, GDUFA, PDUFA