Search Results for user fees

Showing 1 – 25  of 74

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

FDA’s Woodcock to Congress: Pass the GDUFA and BsUFA Reauthorizations By Zachary Brennan - Published 02 March 2017

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, was in the hot seat on Thursday taking questions from the House Energy & Commerce Committee and urging the representatives to pass reauthorizations of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA).

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

Tags: GDUFA, BsUFA, Woodcock, FDA user fees

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

FDA Explains How GDUFA II Will Help Small Businesses By Zachary Brennan - Published 26 January 2017

The US Food and Drug Administration (FDA) on Thursday offered more details on how the second iteration of the Generic Drug User Fee Act (GDUFA), which must be approved by Congress and President Donald Trump by the end of September 2017, will improve upon the first.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: GDUFA II, generic drug user fees, CMO user fees

BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump By Michael Mezher - Published 19 December 2016

The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration.

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

Tags: PDUFA VI, User Fees, Trump, BIO

BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022 By Zachary Brennan - Published 20 October 2016

A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs

Tags: biosimilar, BsUFA, Biosimilar User Fee Act, FDA user fees, BPD meeting

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

Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017 By Zachary Brennan - Published 27 July 2016

As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000.

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

Tags: PDUFA user fee, BsUFA user fee, new drug fees, FDA user fees, 2017 industry fees to FDA

The Next PDUFA: New Performance and Procedural Goals By Zachary Brennan - Published 15 July 2016

Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022.

Categories: News, US, FDA, Business and Leadership, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PDUFA VI, FDA user fees, FDA performance goals 2016

House E&C Committee Clears New Priority Review Voucher Program By Zachary Brennan - Published 14 July 2016

The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset.

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

Tags: PRV, priority review voucher, FDA priority review, user fees for priority drug reviews

Woodcock: FDA Hits ANDA Backlog Reduction Goal Ahead of Schedule By Zachary Brennan - Published 11 July 2016

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule. 

Categories: News, US, CDER, Generic drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, ANDA backlog, generic drug user fees

Pharma Companies: FDA Wants New Info for FY2017 User Fees By Michael Mezher - Published 23 May 2016

The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs

Tags: PDUFA, PDUFA V, User fees

FDA to Congress: GDUFA is Working By Zachary Brennan - Published 30 March 2016

A little more than three years into the user fee program for generic drugs, created under the Generic Drug User Fee Amendments (GDUFA) of 2012, and the US Food and Drug Administration (FDA) is telling Congress that following a major restructuring, the program is working.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: generic drugs, GDUFA, generic drug user fees, ANDA backlog

Biosimilar User Fees: Public Meeting Kicks Off Negotiations for BsUFA II By Zachary Brennan - Published 18 December 2015

The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Quality, Research and development

Tags: BsUFA, biosimilar user fees, biosimilars, follow-on biologics, CDER, CBER, industry

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

PDUFA VI Reauthorization: Industry, FDA Discuss Broader Use of Real World Evidence By Zachary Brennan - Published 23 November 2015

Representatives from industry groups BIO and PhRMA met with officials from the US Food and Drug Administration (FDA) twice last month to discuss new plans for using real world evidence to support benefit-risk assessments for medical products, according to the meeting minutes of a subgroup of the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA).

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: PDUFA VI, PDUFA, FDA, industry meetings, 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

GPhA: Congress Needs to Work With FDA to Increase Generic Competition By Zachary Brennan - Published 03 November 2015

The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday.

Categories: News, US, FDA, Compliance, Distribution, Generic drugs, Prescription drugs, Government affairs, Manufacturing, Quality, Regulatory intelligence

Tags: generic drugs, GPhA, ANDAs, Generic Drug User Fee Amendments of 2012, user fees, Turing Pharmaceuticals

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 Commissioner Outlines Critical Time Ahead for Agency By Zachary Brennan - Published 27 October 2015

As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for new major legislation overhauling parts of its operations, a major transformation is in the works over the next couple of years.

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

Tags: FDA, Ostroff, FDA Commissioner, user fees, AdvaMed

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

Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts By Alexander Gaffney, RAC - Published 26 February 2015

New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget.

Categories: News, US, FDA

Tags: User Fees, PDUFA, MDUFA, BsUFA, AGDUFA, ADUFA, GDUFA, Sequester, Sequestration, Bill, Legislation, Congress

New User Fees Set for Foreign Medical Device Manufacturers in China By Stewart Eisenhart, Emergo - Published 06 February 2015

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

Categories: News, China, CFDA, In vitro diagnostics, Medical Devices

Tags: Emergo, Emergo Group, User Fees, Medical Device User Fees