Search Results for Investigational New Drug Application

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IND Application Fast Facts By Valerie Fauvelle - Published 06 January 2017

This article provides information companies need when filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups.

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

Tags: IND, Investigational New Drug Application

Drug Safety Reports Still Uninformative, FDA Officials Say By Michael Mezher - Published 04 May 2016

Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: Investigational new drug application, IND, expedited safety reports

FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs By Michael Mezher - Published 16 March 2016

The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells.

Categories: News, CBER, Biologics and biotechnology, Clinical, Manufacturing, Research and development

Tags: CAR T-cells, chimeric antigen receptors, CD19, Recombinant DNA Advisory Committee, Cancer, Oncology, Juno, Kite, Novartis, B-cell lymphoma, Investigational new drug application, IND

23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates By Alexander Gaffney, RAC - Published 02 March 2015

Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Compliance, Drugs

Tags: IND, Investigational New Drug Application, Clinical Trial Requirements, 21 CFR 312

FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014 By Alexander Gaffney, RAC - Published 23 January 2015

Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Compassionate Use, Expanded Access, IND, Investigational New Drug Application