Search Results for GDUFA

Showing 1 – 25  of 87

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

Generic Drug User Fee Act (GDUFA): Overview and Proposed Changes for 2018 By Karla Mark-Lantz, PhD - Published 11 May 2017

This article discusses aspects of the Generic Drug User Fee Act enacted by Congress as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), including fees, changes enabling FDA to speed up reviews, GDUFA goals and proposed changes and impacts as the first five–year phase concludes in 2017.

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

Tags: 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

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

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

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

FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing By Zachary Brennan - Published 24 February 2017

While reporting a US savings of $1.68 trillion over the last 10 years for generic drugs, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), also unveiled statistics for another record-setting year in generic drug approvals.

Categories: News, US, FDA, Generic drugs

Tags: Office of Generic Drugs, GDUFA, BsUFA

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

FDA Revises Refuse-to-Receive Guidance for ANDAs By Zachary Brennan - Published 21 December 2016

The second revision of the guidance, unveiled Wednesday, is part of the US Food and Drug Administration’s (FDA) attempt to assist abbreviated new drug application (ANDA) sponsors in understanding what deficiencies may cause FDA to refuse to receive (RTR) an ANDA.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: ANDA, refuse-to-receive an ANDA, GDUFA, generic drugs

'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017 By Michael Mezher - Published 15 December 2016

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017.

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

Tags: CDER 2017 Priorities, 21st Century Cures, PDUFA, GDUFA, BsUFA, Janet Woodcock

GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics By Zachary Brennan - Published 27 October 2016

In the final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) is planning to prioritize the post-market evaluation of generics, work on the equivalence of complex generics and locally acting products, as well as new standards and computational and analytical tools.

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

Tags: GDUFA, generic drugs, FDA science priorities

Updated: GDUFA II Performance Goals: 8-Month Priority Reviews, More Timely Correspondence By Zachary Brennan - Published 17 October 2016

The US Food and Drug Administration (FDA) will speed the review of abbreviated new drug applications (ANDAs) and work with generic drugmakers on a closer and more timely basis, according to the draft performance goals and program enhancements for the Generic Drug User Fee Act (GDUFA) reauthorization for FYs 2018-2022, known as GDUFA II.  

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

Tags: GDUFA II, generic drugs, generic drugs performance goals

FDA Finalizes Guidance on Generic Drug Facility Self-Identification By Zachary Brennan - Published 22 September 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance on information regarding what companies need to self-identify as a producer of generic drugs and what information they must provide to FDA.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Government affairs, Manufacturing

Tags: GDUFA, generic facility self-identification, FDA guidance

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

FDA Lowers ANDA Fee Rates for 2017 By Zachary Brennan - Published 26 July 2016

Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Generic drugs, Government affairs, Manufacturing, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug API manufacturing, GDUFA, generic drug facility fees, FDA fees

Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US By Zachary Brennan - Published 13 July 2016

The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 (GDUFA).

Categories: News, Asia, US, FDA, Compliance, Generic drugs, Manufacturing

Tags: import alert, generic drugs, GDUFA facility fees

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

GDUFA Reauthorization: GPhA and Catalent Make Specific Requests By Zachary Brennan - Published 27 April 2016

As the US Food and Drug Administration (FDA), industry and other stakeholders continue to meet and discuss what provisions the next iteration of the Generic Drug User Fee Act (GDUFA) should contain in 2017, both the Generic Pharmaceutical Association (GPhA) and contract manufacturer Catalent, among others, have outlined particular requests.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs

Tags: GPhA, Catalent, GDUFA II, GDUFA negotiations

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

API DMFs for ANDAs: FDA Finalizes Guidance on Completeness Assessments By Zachary Brennan - Published 12 February 2016

The US Food and Drug Administration (FDA)'s final guidance issued on Friday will help the generic drug industry prepare for completeness assessments for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA).

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Generic drugs, Due Diligence, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Type II DMFs, GDUFA, generic drug applications, ANDAs

FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II By Zachary Brennan - Published 28 January 2016

Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told Senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Due Diligence, Government affairs, Manufacturing, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, generic drugs, Janet Woodcock, Senate HELP, ANDA approvals

Industry Conflicts With FDA: The Options By Zachary Brennan - Published 11 November 2015

Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month.

Categories: News, US, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: FDA, conflict/resolution with FDA, GDUFA, CDER, disputes with FDA, pharma industry disputes, FDA ombudsman

Professors Call on Congress to Make More Info Public on Generic Manufacturers By Zachary Brennan - Published 16 October 2015

As discussions over the reauthorization of the Generic Drug User Fee Amendments (GDUFA) continue, two professors from MIT and the University of Chicago are calling on Congress to require the Food and Drug Administration (FDA) to be more transparent about the companies that manufacture generic drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Manufacturing

Tags: GDUFA, contract manufacturing organizations, ANDA, generic drugs