Search Results for Reauthorization

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CBO Releases Cost Estimate for User Fee Bill By Michael Mezher - Published 19 June 2017

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Government affairs, Medical Devices, Submission and registration

Tags: CBO, User Fees, Reauthorization

User Fee Reauthorization Bill Advances in the House By Michael Mezher - Published 07 June 2017

The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration

Tags: User fees, Reauthorization, FDARA

House Subcommittee Advances User Fee Reauthorizations By Zachary Brennan - Published 18 May 2017

Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars.

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

Tags: E&C, FDA user fees, user fee reauthorization

Senate Committee Advances FDA User Fee Reauthorization Bill By Zachary Brennan - Published 11 May 2017

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, Senate HELP, Hatch, Franken, Collins, FDA user fees

Senate Committee to Vote on FDA User Fee Reauthorizations By Zachary Brennan - Published 03 May 2017

Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements.

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

Tags: user fee reauthorization, Senate HELP committee, FDA user fees

House to Consider MDUFA Add-Ons By Michael Mezher - Published 26 April 2017

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package.

Categories: News, FDA, Medical Devices

Tags: User Fees, Reauthorization, Energy & Commerce

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

Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

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

PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations By Zachary Brennan - Published 22 August 2016

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the user fee program from fiscal years 2018 through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Manufacturing, Quality

Tags: AstraZeneca, PDUFA VI, PDUFA reauthorization, Prescription Drug User Fee Act

MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal By Zachary Brennan - Published 26 February 2016

Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA).

Categories: News, US, CDRH, Government affairs, Medical Devices, Preclinical

Tags: MDUFA, user fee reauthorization, MITA, AdvaMed, ODE, new CDRH hires

PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting By Michael Mezher - Published 15 July 2015

The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA).

Categories: News, US, FDA, Biologics and biotechnology, Communication, Drugs, Submission and registration

Tags: PDUFA, PDUFA VI, PDUFA reauthorization, PhRMA

FDA Kicks off Reauthorization Process for PDUFA By Alexander Gaffney, RAC - Published 12 May 2015

The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug products in the US are reviewed.

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

Tags: PDUFA, FDASIA, PDUFA Reauthorization, PDUFA VI

As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder By Alexander Gaffney, RAC - Published 27 August 2014

In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats.

Categories: News, US, Government affairs

Tags: PAHPRA, Pandemic and All-Hazards Preparedness Reauthorization Act, Biodefense, Campaign Ad

House Meets to Discuss PDUFA, MDUFA User Fees By Alexander Gaffney - Published 18 April 2012

Tags: E&C, Commerce and Energy Committee, Hearing, House, Reauthorization, MDUFA, Latest News, PDUFA

Shuren's Senate Testimony Yields Wealth of Insight By Alexander Gaffney - Published 30 March 2012

Categories: FDA, CDRH

Tags: Testimony, Shuren, Reauthorization, MDUFA, 2012, Latest News, Congress, medical device

Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify By Alexander Gaffney - Published 13 January 2012

Categories: FDA, CDER, CDRH

Tags: Margaret Hamburg, Testify, Hearing, Authorization, House, Law, Janet Woodcock, Reauthorization, MDUFA, Latest News, Jeffery Shuren, GDUFA, PDUFA

UPDATED: FDA Completes Work on Three User Fee Acts, Sends to Congress By Alexander Gaffney - Published 13 January 2012

Categories: FDA

Tags: Kathleen Sebelius, BIPUF, Margaret Hamburg, Reauthorization, User Fee, MDUFA, 2012, Latest News, Congress, GDUFA, PDUFA

Reauthorization of User Fee Acts on Congressional Agenda for 2012 By Alexander Gaffney - Published 04 January 2012

Categories: FDA

Tags: Reauthorization, User Fee, MDUFA, 2012, Latest News, Congress, PDUFA