Search Results for pediatric clinical trials

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FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements By Zachary Brennan - Published 12 September 2017

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Categories: News, US, FDA, Clinical, Drugs

Tags: FDARA, PREA, pediatric clinical trials

Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes By Zachary Brennan - Published 08 March 2017

A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Research and development

Tags: pediatric cancer clinical trials, BPCA, PREA, pediatric clinical trials

CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics By Michael Mezher - Published 16 February 2017

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.

Categories: News, EMA, FDA, Clinical, Drugs

Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative

European Commission Unveils Four New Public Consultations on Clinical Trials By Zachary Brennan - Published 02 June 2016

The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons,” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs).

Categories: News, Europe, EC, EMA, Clinical, Drugs, Government affairs, Quality, Research and development

Tags: European Commission consultation, clinical trials in EU, pediatric clinical trials

After Months of Silence, FDA Returns to 'Name and Shame' Strategy on Pediatric Trial Compliance By Alexander Gaffney, RAC - Published 22 May 2014

In 2013, the US Food and Drug Administration (FDA) launched a new webpage seemingly intended to shame companies into meeting their pediatric study commitments under the Pediatric Research Equity Act (PREA).

Categories: News, US, CDER, Compliance, Drugs

Tags: PREA, BPCA, PREA Noncompliance Letter, CDER, Pediatric, Clinical Trials

After 13 Years, FDA Finalizes Pediatric Trials Protection Rule By Alexander Gaffney, RF News Editor - Published 26 February 2013

Categories: Ethics

Tags: Protections, Pediatric, clinical trials