Pearls of Wisdom
FDA Commissioner Margaret Hamburg releases comments meningitis outbreak
Margaret Hamburg, FDA Commissioner released an article commenting on the recent meningitis outbreak. On September 18, 2012 it was confirmed that a patient in Tennessee had meningitis. By September 27, there had been eight more additional patients with similar...
Canadian Health Authorities exploring extending GMPs to APIs
Per in-Pharma Technologist.com, Regulation Health Canada first publicly introduced the idea of extending good manufacturing practice laws to active pharmaceutical ingredients in the September 2012 publication of the Canada Gazette. It was only this past week that...
ACRP is hosting annual conference November 3, 2012
The Association of Clinical Research Professionals (ACRP) annual conference will be held November 3, 2012 at the University Place Conference Center- IUPUI Campus. The symposium is designed for all personnel who are involved in or planning to be involved in clinical...
FDA releasing two new guidelines affecting medical device submissions and review time
The US Food and Drug Administration’s Center for Devices and Radiological Health has released two new guidance documents which can be read here, relating to how the agency plans to calculate review time and goals for medical device submissions under the Medical Device...
Biotech IPOs can see the light during dark times in biotech venture capital
Too much promising and too little delivering has caused many VC firms to shut their doors. In a recent article by Xconomy the author shares that the majority of biotech VCs are struggling to stay afloat. This is no surprise to the VC industry: there were 1,022 active...