Search Results for GDUFA II

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FDA Revises Priority ANDA Draft Guidance By Michael Mezher - Published 03 November 2017

The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).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The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).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The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA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REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017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

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 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

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

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