Search Results for breakthrough

Showing 1 – 25  of 27

FDA and Pentagon Forge Breakthrough Designation Agreement By Zachary Brennan - Published 16 January 2018

Following the Pentagon’s criticism of the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s (DoD) Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Pentagon, DoD, breakthrough, freeze-dried plasma, platelets

FDA, CMS: Second Parallel Review Decision Ever for NGS Test By Michael Mezher - Published 01 December 2017

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.

Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration

Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device

Breakthrough Devices: FDA Issues Draft Guidance By Michael Mezher - Published 24 October 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance detailing the agency's new program for breakthrough medical devices created by the 21st Century Cures Act.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

Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds By Zachary Brennan - Published 08 September 2017

The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found an association between these expedited pathways and the likelihood of safety-related labeling changes.

Categories: News, US, FDA

Tags: breakthrough drug, accelerated approval, fast track, drug safety, label changes

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

CDRH Plots Path to New 'Progressive' Approvals for Some Devices By Zachary Brennan - Published 03 May 2017

With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: NEST, MDUFA IV, progressive approvals, breakthrough devices

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

CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices By Zachary Brennan - Published 31 May 2016

A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program.

Categories: News, US, CDRH, Clinical, Government affairs, Medical Devices, Postmarket surveillance

Tags: expedited device approvals, EAP, breakthrough devices

Physicians Lack Understanding of What ‘Breakthrough’ Designation Means, Study Finds By Zachary Brennan - Published 12 April 2016

A US survey of board-certified internists and specialists revealed “substantial deficits in knowledge” of what it means for a drug to be approved by the US Food and Drug Administration (FDA) and approved via the “breakthrough” pathway, according to a research letter published in JAMA on Tuesday.

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

Tags: breakthrough therapy, breakthrough designation, FDA approval pathways

FDA Review Times Steadily Decreasing, Report Finds By Zachary Brennan - Published 29 March 2016

Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: FDA review times, FDA approval trends, breakthrough designations

Analysis: Breakthrough Therapies Cut Development Timeline by Two Years By Michael Mezher - Published 11 March 2016

A nonprofit cancer advocacy group says that the US Food and Drug Administration's (FDA) breakthrough therapy designation has been effective in shortening the amount of time it takes to develop new oncology drugs by more than two years.

Categories: News, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Research and development, Submission and registration

Tags: Breakthrough therapy designation, Accelerated approval, Oncology

First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA By Zachary Brennan - Published 26 January 2016

Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options.

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

Tags: FDA approvals, rare disease, first-in-class new drugs, accelerated approval, breakthrough therapy

What Causes Variations in Review at CDER? It's All About the Designation By Michael Mezher - Published 21 August 2015

Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas.

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

Tags: Accelerated review, priority review, fast-track designation, breakthrough therapy designation, CDER

Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices By Alexander Gaffney, RAC - Published 27 April 2015

Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.

Categories: News, US, CDRH, Medical Devices

Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill

Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases By Diane M. Beatty, PhD - Published 30 March 2015

An analysis of the impact of FDA’s four expedited programs on development and review of drugs for serious conditions over the last two-and-a-half years since breakthrough therapy designation was introduced, including a performance summary.

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

Tags: Breakthrough therapy designation, fast track designation, priority review, accelerated approval pathway, unmet medical needs

FDA’s Expedited Programs for Serious Conditions: An Overview By Diane M. Beatty, PhD - Published 30 March 2015

An overview of FDA’s four expedited drug development programs for serious or life-threatening conditions: fast track designation, breakthrough therapy designation, priority review designation and the accelerated approval pathway.

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

Tags: Fast track designation, breakthrough therapy, priority review, accelerated approval, serious conditions, life-threatening conditions

FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes By Alexander Gaffney, RAC - Published 29 May 2014

The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted breakthrough product designation.

Categories: Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Orphan products, Submission and registration

Tags: Breakthrough Product Designation, Expedited Approval, Expedited Programs, Guidance, Breakthrough Product Guidance

FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative By Alexander Gaffney, RAC - Published 21 May 2014

Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration.

Categories: News, US, CDER, Prescription drugs

Tags: Breakthrough Product Designation, PCAST, Report, Legislators, Congress, House

FDA Provides Update on Breakthrough Product Designation Program, Showing Industry Interest By Alexander Gaffney, RF News Editor - Published 12 December 2013

Categories: US, FDA

Tags: Breakthrough Product Designation, approval

In Landmark Move, First Breakthrough Product Obtains FDA Approval By Alexander Gaffney, RF News Editor - Published 01 November 2013

Categories: US, FDA

Tags: Breakthrough Product Designation, approval

Industry Weighs in on Expedited Products Guidance, Calling for Definitional Clarity By Alexander Gaffney, RF News Editor - Published 28 August 2013

Categories: US, FDA

Tags: Breakthrough Product Designation, Comments, PhRMA, guidance

FDA Releases Long-Awaited Guidance on Breakthrough Product Designation By Alexander Gaffney, RF News Editor - Published 25 June 2013

Categories: US, FDA

Tags: Breakthrough Product Designation, Latest News, draft guidance

Pfizer Claims Fourth Breakthrough Product Designation, But Joins Others in Citing Unclear Benefit By Alexander Gaffney, RF News Editor - Published 11 April 2013

Categories: US, FDA

Tags: Breakthrough Product Designation, Pfizer, Breast Cancer

Woodcock Lauds First Submission of 'Breakthrough' Product By Alexander Gaffney, RF News Editor - Published 04 December 2012

Categories: FDA, CDER

Tags: Breakthrough Therapies, Woodcock

Perspective: Advancing Breakthrough Therapies for Patients By Jennifer Dudinak, PharmD - Published 29 June 2012

This article discusses the Advancing Breakthrough Therapies for Patients Act-- a piece of new draft legislation with the goal of reducing total development time and cost of breakthrough treatments, as well as minimizing the number of patients given a "control" regimen known to have limited benefit.

Categories: Features

Tags: Advancing Breakthrough Therapies for Patients Act, ABTP Act, Breakthrough, Legislation, House, Senate, Orphan