Search Results for PREA

Showing 1 – 17

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

FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement By Zachary Brennan - Published 18 August 2017

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

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

Tags: PREA, FDASIA, non-compliance letters FDA

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

Pediatric Study Plans: FDA Unveils Revised Draft Guidance By Zachary Brennan - Published 08 March 2016

The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted.

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

Tags: pediatric study plans, iPSP, PREA, FDASIA

Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act By Michael Mezher - Published 08 December 2015

Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Regulatory strategy, Research and development

Tags: 21st Century Cures, Orphan Product Extensions Now Act, OPEN Act, Pediatric Research Equity Act, PREA, Public Citizen

NIH Wants Safety, Efficacy of Viagra, Epogen and Other Drugs Tested in Children Published 25 August 2014

The National Institutes of Health (NIH) has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on.

Categories: Biologics and biotechnology, Prescription drugs, Labeling

Tags: NIH, BPCA, PREA, Priority List, Priority List of Needs of Pediatric Therapeutics, PLNPT, Pediatric, Children, Kids

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

Researchers: Need for More Neonate-Specific Clinical Drug Research By Alexander Gaffney, RF News Editor - Published 29 October 2012

Categories: FDA

Tags: Neonates, Kids, Pediatric, PREA, BPCA, Latest News, research, article

Study: Pediatric Clinical Trials Remain Scarce By Alexander Gaffney - Published 25 July 2012

Tags: Pediatric, PREA, BPCA, Latest News, study, clinical trials

Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations By Alexander Gaffney - Published 24 April 2012

Categories: FDA

Tags: Publication Bias, Clinical Study, Kids, Children, Pediatric, PREA, BPCA, NIH, Latest News, clinical trial, study

Senators Release Plan to Improve Pediatric Device, Drug Safety By Alexander Gaffney - Published 18 April 2012

Tags: Kids, PMDSA, Children, Pediatric, Legislation, PREA, BPCA, Latest News, Senate, Bill, Congress, pharmaceutical, drug, medical device

PREA, BPCA Reauthorization Bill Introduced in House of Representatives By Alexander Gaffney - Published 29 March 2012

Categories: FDA

Tags: Rogers, Eschoo, Pediatric, Markey, Legislation, PREA, BPCA, House, Latest News, Bill, Congress

IOM Report: Clinical Trials in Kids Working Published 02 March 2012

Tags: IOM, Pediatric, PREA, BPCA, Latest News, clinical trials

IOM: Legislation Has Led To Safer Medicines For Children, More Work Needed By Alexander Gaffney - Published 29 February 2012

Categories: FDA

Tags: Children, IOM, Pediatric, PREA, BPCA, Report, Latest News, study, clinical trials

FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act By Alexander Gaffney - Published 09 February 2012

Categories: FDA

Tags: PREA, Latest News, BPCI, PPACA, draft guidance, Biologics

PDUFA Hearings Highlight Support and Concerns About Legislation By Alexander Gaffney - Published 02 February 2012

Categories: FDA

Tags: Reauthorzation, PREA, BPCA, Margaret Hamburg, Hearing, House, Latest News, Hamburg, PDUFA

PDUFA Witness List Revealed, Hearing Set for Wednesday By Alexander Gaffney - Published 30 January 2012

Categories: FDA

Tags: Reauthorzation, PREA, BPCA, Margaret Hamburg, Hearing, House, Latest News, Hamburg, PDUFA