Search Results for BsUFA

Showing 1 – 25  of 36

FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018 By Zachary Brennan - Published 14 September 2017

With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs.

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

Tags: BsUFA, PDUFA, FDA user fees 2018

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

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

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

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

'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

FDA Officials Share Best Practices for Biosimilar Development By Michael Mezher - Published 28 October 2016

With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars, BsUFA II

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 May Push Back Release of Biosimilar Interchangeability Draft Guidance By Zachary Brennan - Published 22 September 2016

Although the Food and Drug Administration (FDA) has continued to say that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar, interchangeability, BsUFA

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

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

Biosimilar User Fees: FDA and Industry Reach Agreement By Michael Mezher - Published 27 June 2016

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May.

Categories: News, US, FDA, Biologics and biotechnology, Regulatory strategy, Submission and registration

Tags: BsUFA, BsUFA II, Biosimilar User Fee Act

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

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

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

Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed By Alexander Gaffney, RF News Editor - Published 02 December 2013

Categories: US, FDA

Tags: Legislators, Sequestration, Sequester, BsUFA, OMB, User Fees, Letter, House, MDUFA, Latest News, GDUFA, PDUFA

FDA Publishes All User Fee Rates for Fiscal Year 2014 By Alexander Gaffney, RF News Editor - Published 01 August 2013

Categories: US, FDA

Tags: AGDUFA, ADUFA, BsUFA, User Fees, User Fee, MDUFA, Latest News, GDUFA, PDUFA

President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees By Alexander Gaffney, RF News Editor - Published 27 March 2013

Categories: FDA

Tags: CR, Continuing Resolution, President, Budget, BsUFA, User Fees, Legislation, Law, MDUFA, Latest News, Congress, GDUFA, PDUFA

Sebelius Writes to Congress, Reminding Them of Sequester's Impact on User Fees By Alexander Gaffney, RF News Editor - Published 15 February 2013

Categories: FDA

Tags: BCA, Sequester, Budget, BsUFA, User Fees, MDUFA, Sebelius, Latest News, GDUFA, PDUFA