Search Results for TransCelerate

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Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

FDA, NIH & Industry Advance Templates for Clinical Trial Protocols By Michael Mezher - Published 03 May 2017

The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) on Tuesday released the final version of a common template for clinical trial protocols intended to save sponsors of NIH-funded Phase II and III studies both time and money.

Tags: Common protocol template, CPT, TransCelerate BioPharma

TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators By Zachary Brennan - Published 29 June 2016

The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Clinical, Crisis management, Drugs

Tags: TransCelerate, Lilly, Pfizer, AstraZeneca, Amgen

Major Pharmaceutical Companies Join Together to Address Regulatory Challenges By Alexander Gaffney - Published 19 September 2012

Tags: TransCelerate BioPharma, Latest News, partnership, clinical trials, regulatory