Search Results for Accelerated Approval

Showing 1 – 25  of 27

Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017) By Nick Paul Taylor - Published 10 October 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs

Tags: Asia Regulatory Roundup, China accelerated approval, Pfizer, FDC manufacturers

European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017) By Nick Paul Taylor - Published 05 October 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs

Tags: accelerated approval, Swissmedic, CQC, Guido Rasi

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

Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market By Zachary Brennan - Published 15 August 2017

Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks of speeding new drugs and medical devices to market without enough preliminary evidence that they are effective.

Categories: News, US, FDA, Drugs, Ethics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: surrogate measures, accelerated approval, high-risk devices, Rob Califf

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

FDA Officials Defend Agency's Flexibility Under Current Regulatory Framework By Michael Mezher - Published 24 February 2017

Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions.

Categories: News, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Submission and registration

Tags: Real-world data, Accelerated approval

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

China to Begin Priority Reviews of Medical Devices in January 2017 By Zachary Brennan - Published 27 October 2016

China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. 

Categories: News, China, CFDA, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: China priority reviews for devices, accelerated approval for medical 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

Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue By Zachary Brennan - Published 25 August 2016

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures

FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial By Zachary Brennan - Published 11 April 2016

More than 10 years since the US Food and Drug Administration (FDA) offered accelerated approval to EMD Serono’s fertility drug Luveris (lutropin alpha for injection), the agency on Monday announced it’s withdrawing the drug’s approval as the company failed to run a postmarketing study required as a condition of approval.

Categories: News, Europe, US, EMA, FDA, Clinical, Compliance, Crisis management, Drugs, Postmarket surveillance

Tags: accelerated approval, NDA withdrawn, EMD Serono, Luveris

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

CDC, NIH 'Working Closely' With FDA on Zika Response By Michael Mezher - Published 10 February 2016

At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Communication, Government affairs, Submission and registration

Tags: Zika virus, Accelerated approval, CDC, NIH, Anthony Fauci, Tom Frieden

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

FDA and EMA Share Perspectives on Evaluating Ebola Treatments By Michael Mezher - Published 18 January 2016

Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials.

Categories: News, Africa, Europe, US, EMA, FDA, WHO, Biologics and biotechnology, Clinical, Drugs, Ethics, Postmarket surveillance, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: Ebola, Emergency Use Authorization, Animal Rule, Conditional marketing authorisation, Accelerated Approval

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 Guidance Aimed at Accelerating Approval for Some Breast Cancer Treatments By Alexander Gaffney, RAC - Published 07 October 2014

A new final guidance document issued by the US Food and Drug Administration (FDA) outlines the processes by which the regulator will accept surrogate endpoints to support the accelerated approval of treatments intended for high-risk early-stage breast cancer.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Submission and registration

Tags: Breast Cancer, pCR, Clinical Trials, Accelerated Approval, Expedited Approval, Surrogate Endpoints, Guidance, Final Guidance

PhRMA: Recommended Language in FDA Accelerated Drug Labeling Guidance Misleading By Alexander Gaffney, RAC - Published 02 June 2014

Pharmaceutical industry trade group PhRMA has come out forcefully against language contained within a draft guidance document issued in March 2014 by the US Food and Drug Administration (FDA), calling the agency's take on labeling drugs granted accelerated approval potentially confusing to patients and undercutting faith in the regulatory system.

Categories: News, US, FDA, Prescription drugs, Labeling

Tags: PhRMA, Guidance, Accelerated Approval, Draft Guidance, Labeling, Conditional Approval

FDA Releases New Accelerated Approval Labeling Guidance By Alexander Gaffney, RAC - Published 24 March 2014

Categories: US, FDA, Labeling

Tags: Accelerated Approval Labeling, Accelerated Approval, Latest News, pharmaceutical, draft guidance, guidance, drug

CDRH Lays Out Plan for Accelerated Approval Pathway for Devices, Other Improvements By Alexander Gaffney, RAC - Published 06 February 2014

Categories: US, FDA, CDRH

Tags: Accelerated Approval, medical device

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

UK Proposes Reimbursement-based Accelerated Approvals Process By Alexander Gaffney - Published 17 July 2012

Categories: MHRA, Reimbursement

Tags: Scientific Opinion, Accelerated Approval, Approvals, Latest News, UK, NHS

Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study By Alexander Gaffney - Published 07 June 2012

Categories: FDA

Tags: RA, Osteoarthritis, Celebrex, Withdrawal, Arthritis, Pfizer, Accelerated Approval, Rheumatoid Arthritis, Latest News

FDA Releases Draft Guidance for Accelerated Approval of Breast Cancer Treatments By Alexander Gaffney - Published 29 May 2012

Categories: FDA

Tags: pCR, Accelerated Approval, Breast Cancer, Surrogate Endpoint, Latest News, pharmaceutical, clinical trial, draft guidance, drug