Search Results for User Fees

Showing 1 – 25  of 108

FDA Describes New GDUFA II User Fee Structure By Michael Mezher - Published 27 October 2017

The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Submission and registration

Tags: User Fees, GDUFA II

PDUFA VI: FDA Explains User Fee Changes in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: PDUFA VI, prescription drug user fees, draft guidance

HHS Inspector General Finds FDA Spends User Fees Appropriately By Zachary Brennan - Published 05 October 2017

The US Department of Health and Human Services’ (HHS) Office of Inspector General on Thursday released a report finding that the Food and Drug Administration (FDA) generally spent prescription drug user fees appropriately.

Categories: News, US, FDA, Compliance, Drugs, Government affairs

Tags: HHS OIG, user fee expenses, prescription drug user fees

FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo

FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018 By Zachary Brennan - Published 14 September 2017

With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs.

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

Tags: BsUFA, PDUFA, FDA user fees 2018

Congress Takes First Look at User Fee Program for OTC Drugs By Michael Mezher - Published 13 September 2017

The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products.

Categories: News, US, FDA, Over the counter drugs

Tags: OTC Monograph, OMOR, Over-the-Counter Monograph, User Fees

Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018 By Zachary Brennan - Published 28 August 2017

Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements.

Categories: News, US, FDA, Business and Leadership, Compliance, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug user fees, medical device user fees, MDUFA IV, GDUFA II

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

Trump to Sign FDA User Fee Reauthorization Bill By Zachary Brennan - Published 03 August 2017

Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. A spokesman for President Donald Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”

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

Tags: FDA user fees, FDA user fee reauthorization

FDA Details Draft Goals for OTC Monograph User Fee Program By Michael Mezher - Published 01 August 2017

After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program.

Categories: News, US, FDA, Over the counter drugs

Tags: OTC Monograph, User Fees, OMUFA

Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess By Zachary Brennan - Published 01 August 2017

Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the bipartisan US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week.

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

Tags: FDA user fees, BsUFA, GDUFA, PDUFA, MDUFA, drug prices, Medicare

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