Search Results for user fee reauthorization

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House Subcommittee Advances User Fee Reauthorizations By Zachary Brennan - Published 18 May 2017

Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars.

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

Tags: E&C, FDA user fees, user fee reauthorization

Senate Committee Advances FDA User Fee Reauthorization Bill By Zachary Brennan - Published 11 May 2017

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September.

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

Tags: user fee reauthorization, Senate HELP, Hatch, Franken, Collins, FDA user fees

Senate Committee to Vote on FDA User Fee Reauthorizations By Zachary Brennan - Published 03 May 2017

Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements.

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

Tags: user fee reauthorization, Senate HELP committee, FDA user fees

Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees By Zachary Brennan - Published 14 April 2017

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, FDA user fees, drug review fees

Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

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

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

GOP Sets June Deadline for Completing FDA User Fee Reauthorizations By Zachary Brennan - Published 06 February 2017

Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Medical Devices, Research and development

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

MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal By Zachary Brennan - Published 26 February 2016

Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA).

Categories: News, US, CDRH, Government affairs, Medical Devices, Preclinical

Tags: MDUFA, user fee reauthorization, MITA, AdvaMed, ODE, new CDRH hires