Search Results for IND

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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

Companies Producing Drugs Only for INDs Exempt From FDA Registration By Zachary Brennan - Published 12 December 2016

The US Food and Drug Administration (FDA) on Monday published a correction to a recent final rule on registering foreign and domestic manufacturing establishments, clarifying that a company producing solely products for investigational new drug (IND) applications is exempt from registration.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: FDA registration for manufacturing, IND manufacturing, drug establishment manufacturing

Microbial Vectors Used for Gene Therapy: FDA Offers Final Guidance By Zachary Brennan - Published 16 September 2016

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research this week issued final guidance for investigation new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early-phase clinical trials.

Categories: News, US, CBER, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: gene therapies, FDA guidance, IND guidance

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

Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs By Zachary Brennan - Published 17 February 2016

A number of drugmakers are calling on the US Food and Drug Administration (FDA) to be more flexible with sponsors in developing guidance on safety assessments for investigational new drug (IND) applications, according to comments published Wednesday on the draft document.

Categories: News, US, EMA, FDA, Clinical, Compliance, Drugs, Due Diligence, Postmarket surveillance, Quality, Submission and registration

Tags: IND safety reporting, safety assessment committee, FDA draft guidance

FDA Offers Draft Guidance on IND Safety Reporting By Zachary Brennan - Published 16 December 2015

For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Due Diligence, Government affairs, Postmarket surveillance, Preclinical

Tags: IND safety reporting, clinical trials adverse events, adverse event reporting, unblinding clinical trial data

New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA By Zachary Brennan - Published 06 December 2015

Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Preclinical, Project management, Quality, Regulatory strategy, Research and development, Submission and registration

Tags: FDA-sponsor meetings, FDA guidance, IND guidance, drug application guidance, FDA and pharma industry communications

FDA Warns California Ophthalmologist Again Over Clinical Trial Violations By Zachary Brennan - Published 02 December 2015

For the second time since 2000, the US Food and Drug Administration (FDA) has sent a warning letter to a Newport Beach, California-based ophthalmologist over objections to a clinical trial run by him.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Medical Devices, Quality

Tags: Warning Letter, ophthalmologist, IND, eye surgery

FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years By Alexander Gaffney, RAC - Published 07 May 2015

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week.

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

Tags: eCTD, Electronic Common Technical Document, NDA, BLA, IND, 505(b)(2), DMF, BPF

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

Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program By Alexander Gaffney, RAC - Published 04 February 2014

In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work.

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

Tags: Investigational IND, Early Access Program, Compassionate Use Program, Regulatory Explainer, Compassionate Use, IND, Expanded Access

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

FDA Wants Input on How to Improve Clinical Trials Process for Industry By Alexander Gaffney, RAC - Published 28 October 2014

The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process.

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

Tags: IND, Communication, Guidance, PDUFA

Senators Want Detailed Data on FDA's Compassionate Use Program, Including Potential Improvements By Alexander Gaffney, RAC - Published 19 June 2014

Three Republican legislators are pressing the US Food and Drug Administration (FDA) to provide them with information about its application of its expanded access regulations, saying they are in the midst of performing "oversight" over the program.

Categories: News, US, CBER, CDER, Clinical, Government affairs

Tags: Compassionate Use, Expanded Access, Expanded Access IND, Expanded Access Protocol

Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs By Alexander Gaffney, RAC - Published 17 March 2014

Categories: US, FDA

Tags: NDA Supplement, BA/BE, Regulatory Explainer, BA, Bioavailability, BE, IND, Latest News, pharmaceutical, bioequivalence, draft guidance, NDA

CBER Finalizes Two Guidance Documents on Use of Hematopoietic Progenitor Cells By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Hematopoietic, Cord Blood, HPC, Minimal Manipulation, Final Guidance, BLA, IND, Latest News, guidance

As Supplement Industry Highlights Problems, FDA Reopens IND Guidance for Comment By Alexander Gaffney, RAC - Published 10 February 2014

Categories: US, FDA

Tags: Dietary Supplement, Comment, IND, Latest News, draft guidance, guidance

FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies By Alexander Gaffney, RF News Editor - Published 10 September 2013

Categories: US, FDA

Tags: Human Research, IND, Latest News, studies, guidance, clinical trials

Final FDA Guidance on IRBs Illustrates Common Problems Faced in Trial Setup Phase By Alexander Gaffney, RF News Editor - Published 27 August 2013

Categories: US, FDA

Tags: Clinical Investigator, IRB, IDE, IND, Latest News, guidance, clinical trials

Safety Main Challenge to Preparing INDs for Cellular and Gene Therapy Products, Says FDA By Alexander Gaffney, RF News Editor - Published 03 July 2013

Categories: US, FDA

Tags: Gene Therapy, IND, draft guidance

FDA Scrapping IND Approach for Fecal Transplants, Developing Guidance on New Approach By Alexander Gaffney, RF News Editor - Published 18 June 2013

Categories: US, FDA

Tags: IND

FDA Guidance Covers Clinical, Regulatory, Filing Considerations for Co-Developed Drugs By Alexander Gaffney, RF News Editor - Published 14 June 2013

Categories: US, FDA

Tags: IND, pharmaceutical, guidance, drug

Fecal Transplant—a Very Unusual Treatment Method By Max Sherman - Published 05 June 2013

Could anyone imagine a medical condition that would warrant administering a stool specimen from a donor? It just so happens that such treatment first occurred more than 50 years ago, and continues today.

Categories: US, FDA

Tags: C. Diff, C. Difficile, Stool, Fecal Transplant, Science and Technology, IND

New FDA Draft Guidance Aims to Clarify Compassionate Use Process By Alexander Gaffney, RF News Editor - Published 09 May 2013

Categories: US, FDA

Tags: Compassionate Use, IND