Search Results for PDUFA

Showing 1 – 25  of 98

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

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

The Prescription Drug User Fee Act (PDUFA): A Primer By Valerie Fauvelle, MS, RAC, Meredith Brown-Tuttle, RAC, FRAPS - Published 25 April 2017

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

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

Tags: User Fees, Prescription Drug User Fee Act, PDUFA

PhRMA Seeks More Transparency on FDA Inspections to Speed First-Cycle Approvals By Zachary Brennan, Michael Mezher - Published 11 April 2017

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week said it supports the US Food and Drug Administration's (FDA) review of its inspection information flow, particularly as applications that receive on-time inspections typically receive first cycle approvals earlier.

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

Tags: First Cycle Reviews, PhRMA, PDUFA V, PDUFA VI

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

Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire By Michael Mezher - Published 22 March 2017

Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).

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

Tags: PDUFA VI, Prescription Drug User Fee Act

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 to Discuss Autism and Available Treatments in May By Zachary Brennan - Published 03 March 2017

An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches.

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

Tags: FDA meetings, PDUFA, autism

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

CBER Director Touts Center's FY2016 Performance By Michael Mezher - Published 06 January 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: CBER, PDUFA, MDUFA, BLA

BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump By Michael Mezher - Published 19 December 2016

The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration.

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

Tags: PDUFA VI, User Fees, Trump, BIO

'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

PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals By Zachary Brennan - Published 24 August 2016

More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO are pleased with the performance goals outlined by and for the agency from 2018 to 2022.

Categories: News, US, FDA, Business and Leadership, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PhRMA, BIO, PDUFA VI, Prescription Drug User Fee Act

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

PDUFA VI: Highlights on What to Expect By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.

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

Tags: PDUFA, PDUFA VI, real-world evidence, Sentinel, model-informed drug development

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

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

Pharma Companies: FDA Wants New Info for FY2017 User Fees By Michael Mezher - Published 23 May 2016

The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year.

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

Tags: PDUFA, PDUFA V, User fees

PDUFA VI Reauthorization: Industry, FDA Discuss Broader Use of Real World Evidence By Zachary Brennan - Published 23 November 2015

Representatives from industry groups BIO and PhRMA met with officials from the US Food and Drug Administration (FDA) twice last month to discuss new plans for using real world evidence to support benefit-risk assessments for medical products, according to the meeting minutes of a subgroup of the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA).

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: PDUFA VI, PDUFA, FDA, industry meetings, user fees

FDA Raises Fee Rate for FY16 Tropical Disease Priority Reviews By Zachary Brennan - Published 11 September 2015

The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016.

Categories: News, US, FDA, Prescription drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Priority Review voucher, FDA, tropical disease priority review, malaria, dengue, PDUFA