FDA Diabetes Guidance To Be Challenged In Petition From Doctors, Patients
This article was originally published in The Pink Sheet Daily
Advocates aim to collect 20,000 signatures for a petition urging looser CV testing standards which will be presented to FDA in March.
You may also be interested in...
FDA's flexibility in applying its new guidance for cardiovascular safety of diabetes drugs will be tested in coming months as it reviews a handful of pending NDAs and enters into discussions about other drugs in late stages of development
In raising pre-market safety standards, FDA says that development time will not necessarily increase if a robust protocol is used.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.