Search Results for Breakthrough Therapy

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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

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

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