Article: Washington Roundup Drugmakers Failed to Keep Pledges for Phase IV Studies.(Report)

Article: FDA's Phase IV Data Prompt Criticism On ...
BIOWORLD Today;  February 5, 2007 ;     700+ words ... ... two-thirds of Phase IV trials, totaling ... Sept. 30. The FDA classifies them ... Congress to fund the FDA at a sufficient ... reviews of these Phase IV studies," said ... proposed giving the FDA more teeth to enforce Phase IV commitments. Recently ...

Article: Agreement reached with FDA regarding phase ...
Medical Letter on the CDC & FDA;  September 12, 2004 ;     700+ words ... ... Drug Administration (FDA) concerning a clinical ... obligation to conduct a phase IV post-marketing clinical ... is approved under the FDA's accelerated approval ... agreement concerning the phase IV trial design and has initiated ... no guarantee that the FDA will approve Riquent ...

Article: FDA Extends Timeline for Completion of Remodulin(R) ...
PR Newswire;  August 21, 2003 ;     638 words ... ... Drug Administration (FDA) has issued new timelines ... completion of a required Phase IV postmarketing study to ... arterial hypertension. The FDA agreed to allow United ... Therapeutics agreed with the FDA to conduct the Phase IV study at the time that ...

Article: FDA EXTENDS TIMELINE FOR COMPLETION OF REMODULIN ...
Biotech Business;  October 1, 2003 ;     600 words ... ... completion of a required Phase IV postmarketing study to ... arterial hypertension. The FDA agreed to allow United ... December 2, 2005. The FDA also agreed to a reduction ... Therapeutics agreed with the FDA to conduct the Phase IV study at the time that ...

Article: Agreement reached With FDA for lupus drug phase ...
Biotech Business Week;  August 23, 2004 ;     700+ words ... ... Drug Administration (FDA) concerning a clinical ... obligation to conduct a phase IV post-marketing clinical ... is approved under the FDA's accelerated approval ... agreement concerning the phase IV trial design and has initiated ... no guarantee that the FDA will approve Riquent ...

Article: Congresswoman Calls For More FDA Power On Phase ...
BIOWORLD Today;  November 3, 2009 ;     700+ words ... ... week, would give the FDA authority to pull products ... drug makers shirk their Phase IV responsibilities. It ... that Congress give the FDA power to mandate post ... Committee, which has FDA jurisdiction and oversight ... approvals come with mandated Phase IV requirements. NIH ...

Article: FDA says most Phase IV studies "not ...
Pharma Marketletter;  February 19, 2007 ;     700+ words ... ... Of the 1,259 pending Phase IV studies up to September ... been submitted to the FDA for review or terminated ... t being done and the FDA doesn't even have the ... applicants was a problem. An FDA spokeswoman told the Bloomberg ... ability to monitor and track Phase IV studies.