U.K. Developing Pediatric Research Initiative Ahead Of EU Legislation
This article was originally published in The Pink Sheet Daily
The British regulatory agency’s proposal would offer scientific advice and waive fees for applications that include pediatric data in labeling. An EU-wide regulation on pediatric incentives is not expected before 2006.
You may also be interested in...
The lack of information on pediatric use of drugs remains a problem in Europe, EC's Brunet tells DIA EuroMeeting in Prague. A draft proposal would create a new marketing authorization system and provide data exclusivity to incentivize pediatric studies in off-patent drugs.
Senior VP-Global Clinical & Pharmaceutical Development Elliott Sigal is acting president of Bristol-Myers Squibb’s research institute following the death of James Palmer.
The company is talking with oncologists about Aranesp ahead of a switch in Medicare reimbursement in January 2005. U.S. sales for the red blood cell product were up 32% in the third quarter.