Search Results for User Fees

Showing 1 – 25  of 97

Senate Appropriations Bill Maintains FDA Funding for 2018 By Michael Mezher - Published 18 July 2017

The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Government affairs

Tags: Appropriations, FY2018, User Fees, Budget

Update: Gottlieb Lays Out Plans to Bolster FDA's Staff By Michael Mezher - Published 17 July 2017

Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs.

Categories: News, US, FDA

Tags: Recruitment, Hiring, Vacancies, User Fees

White House Doubles Down on Call to Fund FDA Entirely With Industry Fees By Zachary Brennan - Published 13 July 2017

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

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

Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill

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

House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess By Zachary Brennan - Published 11 July 2017

The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off.

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

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

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

GAO: FDA Needs a Plan for GDUFA Carryover Fees By Michael Mezher - Published 27 June 2017

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: GDUFA, User Fees, Carryover, Government Accountability Office, GAO

CBO Releases Cost Estimate for User Fee Bill By Michael Mezher - Published 19 June 2017

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Government affairs, Medical Devices, Submission and registration

Tags: CBO, User Fees, Reauthorization

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

Navigating the Medical Device User Fee Act (MDUFA) By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA - Published 25 May 2017

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Features, US, CDRH, Medical Devices, Submission and registration

Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees

Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming By Zachary Brennan - Published 25 May 2017

US Food and Drug Administration (FDA) commissioner Scott Gottlieb was in the hot seat on Thursday to defend President Donald Trump's budget plan to the House appropriations committee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed in the budget and revealed that FDA as of Thursday is no longer subject to a hiring freeze.

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

Tags: Scott Gottlieb, FDA budget 2018, FDA user fees, drug prices

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

HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees By Zachary Brennan - Published 17 May 2017

Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations.

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

Tags: Tom Price, MDUFA IV, BsUFA II, PDUFA VI, GDUFA, user fees

Congress to Trump: Let’s Tackle Drug Pricing in User Fee Reauthorizations By Zachary Brennan - Published 15 May 2017

As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office.

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

Tags: drug pricing, Trump, FDA user fees

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

FDA User Fee Programs By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA - Published 08 May 2017

This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies.

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

Tags: User Fees, PDUFA, MDUFA, GDUFA

User Fee Reauthorization Bill Amended Ahead of Wednesday Vote By Zachary Brennan - Published 08 May 2017

Ahead of Wednesday’s Senate health committee vote on the five-year reauthorizations of the US Food and Drug Administration (FDA) user fee agreements, the committee has released an updated version of the legislation that includes several medical device bills discussed on the House side.

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

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

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

Government Spending Bill Would Boost FDA Funds by Almost $40M By Zachary Brennan - Published 01 May 2017

The US House and Senate appropriations committees on Monday released government spending bills through the end of this fiscal year, offering the US Food and Drug Administration (FDA) a boost in discretionary spending.

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

Tags: FDA budget, FY2017 budget, FDA user fees

House to Consider MDUFA Add-Ons By Michael Mezher - Published 26 April 2017

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package.

Categories: News, FDA, Medical Devices

Tags: User Fees, Reauthorization, Energy & Commerce

The Prescription Drug User Fee Act (PDUFA): A Primer By Valerie Fauvelle, MS, RAC, Meredith Brown-Tuttle, RAC, FRAPS - Published 25 April 2017

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

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

Tags: User Fees, Prescription Drug User Fee Act, PDUFA

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

Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs By Zachary Brennan - Published 04 April 2017

Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.

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

Tags: user fees, PDUFA, BsUFA, MDUFA, GDUFA, AdvaMed, BIO, AAM

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

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

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

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