Search Results for GDUFA

Showing 1 – 25  of 104

Updated: Generic Drug Monthly Dashboard: FDA Adds New Metrics By Zachary Brennan - Published 13 December 2017

The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.

Categories: News, US, FDA, Generic drugs

Tags: generic drug activity, GDUFA II

FDA Sets Monthly ANDA Records in October By Michael Mezher - Published 14 November 2017

The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments (GDUFA).

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

Tags: ANDAs, GDUFA II, Complete Responses

FDA Expands Generic Drug Priority Reviews By Zachary Brennan - Published 09 November 2017

Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue.

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

Tags: generic drug review, generic drug approval, GDUFA

FDA Revises Priority ANDA Draft Guidance By Michael Mezher - Published 03 November 2017

The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).

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

Tags: Priority ANDAs, GDUFA II, Pre-Submission Facility Correspondence, PFC

FDA Drafts Guidance on Controlled Correspondence Under GDUFA II By Zachary Brennan - Published 02 November 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).

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

Tags: GDUFA II, controlled correspondence, generic drug correspondence

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The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA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

REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

Categories: News, US, FDA, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: REMS, REMS document, FDA draft guidance, GDUFA II

Status Updates for ANDAs: FDA Spells Out GDUFA II Provision By Zachary Brennan - Published 06 October 2017

Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.

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

Tags: GDUFA II, ANDA status updates

Another Record Year for US Generic Drug Approvals in 2017 By Zachary Brennan - Published 05 October 2017

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report.

Categories: News, US, CDER, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug approvals, GDUFA, 2017 generic drug approvals

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

FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II By Zachary Brennan - Published 22 August 2017

Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).

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

Tags: FDARA, GDUFA, pre-submission guidance

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

FDA Finalizes GDUFA Q&A Guidance By Michael Mezher - Published 25 July 2017

The US Food and Drug Administration (FDA) on Tuesday finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues.

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

Tags: Guidance, GDUFA, Abbreviated New Drug Application, Self-Identification

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

FDA Speeding Generic Drug Approvals: Not Just Lip Service By Zachary Brennan - Published 10 July 2017

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

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

Tags: FDA generic drug approvals, GDUFA, ANDA approvals

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

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