Search Results for fast track

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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

Swissmedic Touts 2016 Performance: 42 New Approvals By Michael Mezher - Published 30 May 2017

In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure.

Categories: News, Europe, Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration

Tags: Swissmedic, new active substance, New chemical entity, fast track

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

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 Fast Tracks Fecal Transplant Product Intended to Treat Clostridium Difficile Infections By Alexander Gaffney, RF News Editor - Published 25 June 2013

Categories: US, FDA

Tags: Fast Track

Study: Are FDA's Expedited Approval Pathways Worth the Risk? By Alexander Gaffney - Published 05 September 2012

Categories: FDA

Tags: Expedited Approval, Fast Track, Priority Review, Accelerated Approval, Latest News, pharmaceutical, drug

Bill Looks to Establish Provisional Approval Framework for Some Products By Alexander Gaffney - Published 09 August 2012

Categories: FDA

Tags: Partial Approval, Provisional Approval, Fast Track, Conditional Approval, Bilbray, Legislation, House, Latest News, Bill, Congress