Search Results for PDUFA VI

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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

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

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

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

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

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

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

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

With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations By Alexander Gaffney, RAC - Published 06 August 2014

The Biotechnology Industry Organization (BIO), a trade group which represents biopharmaceutical companies, is launching a new tracking tool meant to assess how companies interact with the US Food and Drug Administration (FDA) in the hopes of improving the drug development process, it announced today.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Prescription drugs

Tags: BIO, PDUFA, PDUFA VI, FDA Interactions, FDA Survey