Search Results for MDUFA

Showing 1 – 25  of 94

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

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

FDA Seeks Input on Device Accreditation Pilot By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions.

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

Tags: Accreditation Scheme for Conformity Assessment, ASCA, MDUFA IV, Consensus Standards

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

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

CDRH Plots Path to New 'Progressive' Approvals for Some Devices By Zachary Brennan - Published 03 May 2017

With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: NEST, MDUFA IV, progressive approvals, breakthrough devices

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

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

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

CBER Director Touts Center's FY2016 Performance By Michael Mezher - Published 06 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: CBER, PDUFA, MDUFA, BLA

Lead MDUFA Negotiator Details Changes in MDUFA IV Financing By Michael Mezher - Published 02 November 2016

The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday.

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

Tags: MDUFA IV, Medical Device User Fee Act

MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA By Zachary Brennan - Published 26 October 2016

The US Food and Drug Administration (FDA) on Tuesday proposed increasing user fees for medical device manufacturers by more than $320 million over the next five years, according to a draft proposal for MDUFA IV.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDUFA, medical device user fee, user fee proposal

Almost 90% of PMA Applicants Received Major Deficiency Letter on First FDA Review Cycle in 2016 By Zachary Brennan - Published 09 September 2016

New data from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) show that through the first six months of 2016, 89% of premarket approval applications (PMAs) received a major deficiency letter in the first review cycle.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, PMA approvals, major deficiency letters

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

FDA Unveils User Fee Rates for FY 2017 By Michael Mezher - Published 01 August 2016

In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself.

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

Tags: User Fees, PDUFA, BsUFA, MDUFA, GDUFA, FY2017

Medical Device Companies to See Slight Discount in FDA User Fees in 2017 By Zachary Brennan - Published 28 July 2016

Medical device companies will see a modest decrease in application fees for FY 2017 when compared to 2016, according to new rates released Thursday by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Compliance, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDUFA, medical device user fees

MDUFA IV: Negotiations Step Forward, But Gaps Remain By Michael Mezher - Published 26 May 2016

The medical device industry is calling for the US Food and Drug Administration (FDA) to add 91 new employees as part of the latest talks over the next version of the Medical Device User Fee Act (MDUFA), though industry also says it needs more information on several recent FDA proposals.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDUFA IV

FDA Outlines Medical Device Real-World Evidence User Fee Proposal By Zachary Brennan - Published 23 May 2016

Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE).

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance

Tags: MDUFA, Medical Device User Fee Act, real-world evidence and medical devices

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

MDUFA IV Negotiations: FDA, Industry Propose New Performance Goals By Zachary Brennan - Published 10 December 2015

At the November meeting on the fourth iteration of the Medical Device User Fee Act (MDUFA IV), the US Food and Drug Administration (FDA) and industry representatives both unveiled new performance targets for de novo submissions, pre-submissions and third-party 510(k) reviews.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Postmarket surveillance, Preclinical, Quality, Reimbursement

Tags: MDMA, MITA, AdvaMed, medical device, MDUFA, FDA user fees

FDA, Stakeholders Reveal Top Priorities for MDUFA IV Reauthorization By Zachary Brennan - Published 12 November 2015

As the US Food and Drug Administration (FDA) and industry look to deliver recommendations to Congress on the reauthorization of the Medical Device User Fee Amendments (MDUFA) by January 2017, both sides agreed to limit their focus to three top priorities for future stakeholder meetings.

Categories: News, US, CDRH, Business and Leadership, Clinical, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: CDRH, MDUFA, user fees, FDA, clinical trials, medical device

FDA, Industry See Progress in MDUFA IV Negotiations By Zachary Brennan - Published 30 October 2015

At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction.

Categories: Business Skills, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDUFA IV, user fees, IDEs, Q-submissions, MDMA, MITA, AdvaMed, ACLA, Booz Allen

FDA Unveils User Fee Rates for FY2016 By Michael Mezher - Published 04 August 2015

The US Food and Drug Administration (FDA) has just released the rates for the various user fees charged to industry for fiscal year 2016.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Submission and registration, Veterinary products

Tags: PDUFA, MDUFA, GDUFA, ADUFA, AGDUFA, User fees

FDA Kicks Off MDUFA Reauthorization Process By Alexander Gaffney, RAC - Published 18 May 2015

The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities.

Categories: News, US, CDRH, Medical Devices

Tags: MDUFA, Medical Device User Fee Act, MDUFA IV