Search Results for FDA user fees

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Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees By Zachary Brennan - Published 14 April 2017

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, FDA user fees, drug review fees

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

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

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

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

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 Announces all User Fees to be Paid by Pharma, Device Industries in 2015 By Alexander Gaffney, RAC - Published 01 August 2014

The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs.

Categories: News, US, CBER, CDER, CDRH, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Submission and registration, Veterinary products

Tags: PDUFA, MDUFA, BsUFA, GDUFA, ADUFA, AGDUFA, Outsourcing Fee, User Fee, FDA User Fees, FY 2015 User Fees