Search Results for Priority Review

Showing 1 – 25  of 66

Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss By Zachary Brennan - Published 08 December 2017

The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and projects, though whether PRVs have actually spurred new research remains a question.

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

Tags: priority review voucher, neglected tropical disease, rare pediatric disease

As Transparency on Priority Review Vouchers Fades, Prices Level Off By Zachary Brennan - Published 29 November 2017

In the early days of the priority review voucher (PRV) programs, back in 2014 and 2015, companies publicly disclosed who they sold the PRVs to, how much they cost and which products they were eventually used to speed the review of.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: priority review vouchers, transparency, PRV prices

Breakthrough Devices: FDA Issues Draft Guidance By Michael Mezher - Published 24 October 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance detailing the agency's new program for breakthrough medical devices created by the 21st Century Cures Act.

Categories: News, US, FDA, Medical Devices, Regulatory strategy, Submission and registration

Tags: Breakthrough Devices Program, Priority Review

How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs By Zachary Brennan - Published 15 August 2017

As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop.

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

Tags: priority review vouchers, biodefense, medical countermeasures

Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate By Michael Mezher - Published 09 August 2017

A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits.

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

Tags: Priority Review, Accelerated Approval, Fast Track, Breakthrough Therapy

Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017) By Nick Paul Taylor - Published 27 June 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, ICH, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals

FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition By Zachary Brennan - Published 27 June 2017

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drugs, priority review of generics, drug price competition, drug prices

FDA Approves First Treatment for a Form of Batten Disease By Zachary Brennan - Published 27 April 2017

The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV).

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

Tags: Batten disease, priority review voucher, PRV, Stivarga, Brineura, Bayer, Biomarin

FDA Officials: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval By Michael Mezher - Published 29 March 2017

A team of officials from the US Food and Drug Administration (FDA) say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market.

Categories: News, US, FDA, Drugs, Labeling, Product withdrawl and retirement

Tags: Boxed Warning, Priority Review

Sarepta Sells Priority Review Voucher for $125M to Gilead By Zachary Brennan - Published 21 February 2017

Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months.

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

Tags: Sarepta, Gilead, priority review voucher, PRV, Cures

Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways By Zachary Brennan - Published 31 October 2016

As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways.

Categories: News, Oceania, EMA, FDA, Health Canada, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: faster drug approval, accelerated approval, priority review for drugs, international drug regulators

Global Regulatory Strategy By Prerna Menon - Published 11 October 2016

This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers.

Categories: Features, Japan, Canada, Europe, US, EMA, FDA, Health Canada, MHLW, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake

FDA Finalizes Guidance on Tropical Disease PRVs, Offering a Number of Clarifications By Zachary Brennan - Published 05 October 2016

The US Food and Drug Administration (FDA) on Wednesday finalized guidance on tropical disease priority review vouchers (PRVs), clarifying when a voucher can be used, whether drugmakers are “guaranteed” a six-month review when using a voucher and whether FDA can remove a tropical disease from the list of considered diseases (it can’t).

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

Tags: priority review vouchers, PRV, rare tropical disease

Priority Review Voucher Fees to Decline in FY 2017 By Zachary Brennan - Published 29 September 2016

The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year.

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

Tags: priority review vouchers, PRV, rare pediatric disease voucher, golden ticket, tropical disease priority review voucher

Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program By Zachary Brennan - Published 28 September 2016

The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December.

Categories: News, US, FDA, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: rare pediatric priority review voucher, PRV program, PRV extension, Bob Casey

Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls By Zachary Brennan - Published 22 September 2016

Congress and President Barack Obama have one week to reauthorize the pediatric priority review voucher (PRV) program, which will sunset on 30 September 2016 after seven pediatric PRVs have been awarded, one of which sold for $350 million last year.

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

Tags: priority review vouchers, PRV, pediatric PRV, Sarepta, Janssen, Alexion

House E&C Committee Clears New Priority Review Voucher Program By Zachary Brennan - Published 14 July 2016

The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset.

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

Tags: PRV, priority review voucher, FDA priority review, user fees for priority drug reviews

House Looks to Reform Tropical Disease Priority Review Voucher Program By Zachary Brennan - Published 08 June 2016

The House Energy and Commerce Committee on Wednesday passed by voice vote an amendment (to an unrelated bill on hospital preparedness for dangerous threats) that would significantly change the priority review voucher (PRV) program for tropical diseases.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Research and development

Tags: priority review voucher, tropical disease voucher, FDA expedited review, new drugs for rare disease

Researchers Urge Caution on Expanding Priority Review Voucher Programs By Zachary Brennan - Published 06 May 2016

As Congress looks to further expand current priority review voucher (PRV) programs (and even create entirely new ones), researchers are now cautioning that the worth of the vouchers could decline significantly and diminish incentives to develop drugs for neglected diseases.

Categories: News, US, FDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: priority review vouchers, PRV, tropical disease treatments, pharmaceutical incentives

Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US By Zachary Brennan - Published 21 April 2016

As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, US, EMA, FDA, WHO, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Medical Devices

Tags: Global Health Technologies Coalition, FDA scientific opinions, FDA task force, priority review voucher

Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms By Zachary Brennan - Published 18 March 2016

Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun.

Categories: News, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: generic competition, priority review voucher, PRV program, Zika PRV, generic PRV

Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills By Zachary Brennan - Published 09 March 2016

The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Quality, Research and development

Tags: Zika, priority review voucher, pediatric PRV program

More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program By Zachary Brennan - Published 03 March 2016

In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics.

Categories: News, US, FDA, Generic drugs, Government affairs, Research and development, Submission and registration

Tags: generic drugs, priority review voucher, Janet Woodcock, Susan Collins

FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness By Zachary Brennan - Published 02 March 2016

The US Government Accountability Office (GAO) said Wednesday in a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases.

Categories: News, US, FDA, Active pharmaceutical ingredients, Clinical, Drugs, Government affairs, Manufacturing, Research and development, Submission and registration

Tags: PRV, priority review voucher, pediatric rare diseases

Asia Regulatory Roundup: CFDA Builds Priority Review Pathway for Drug Approvals (1 March 2016) By Nick Paul Taylor - Published 01 March 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.  

Categories: News, Asia, CDSCO, CFDA, PMDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality, Research and development

Tags: Asia Regulatory Roundup, China priority review, Indian budget, Malaysia medical devices