Medical Letter on the CDC & FDA
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC & FDA
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Biopure Corporation
Biopure Announces Date to Meet with UK's Medicines and Healthcare Products Agency
May 18th, 2008
Biopure Corporation (NASDAQ:BPUR) announced that a meeting with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) is scheduled for May 29, 2008 in the UK. The purpose of the meeting is to clarify the issues outlined in a letter Biopure received in April 2008 from the United Kingdom's Commission on Human Medicines regarding the company's application for marketing authorization for Hemopure(R). The issues relate to quality, clinical efficacy, safety and the reliability of data monitoring and auditing of clinical trials. The letter stated that the Commission was "reassured" on a number of the questions raised in its initial comment letter, but...
Source: Medical Letter on the CDC & FDA (2008-05-18)
|
