31 Drugs Facing FDA Approval in 2012-2013
Posted on | August 21, 2012 | Comments Off
“Here’s an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013. This refresh includes changes and additions to the FDA calendar last published at the end of July. ” http://www.thestreet.com/story/11668461/1/31-drugs-facing-fda-approval-in-2012-2013.html
UK overhauls drug laws with new Human Medicines Regulations
Posted on | August 20, 2012 | Comments Off
New Human Medicines Regulations came into effect this morning, overhauling the UK’s regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
A Total Mess at the FDA?
Posted on | July 26, 2012 | Comments Off
Derek Lowe, writes for “In the Pipeline”. Check out his investigation of the total mess at the FDA and employee surveillance scandal to brew! Wow, I hope these stories aren’t true. It sounds like a terrible place to work, with many other issues to boot.
No action taken to withdraw 33 untested drugs from market after one month
Posted on | June 14, 2012 | Comments Off
“Even though one month has passed since the Parliamentary Standing Committee on Health’s startling revelations that the Drug Controller General of India (DCGI) has approved as much as 33 drugs without clinical trial on Indian patients during the period of January 2008 to October 2010, all the controversial drugs are still in the market with the Indian regulator contemplating no action on the issue in the immediate future…more“
US clears drugs faster than Europe, Canada
Posted on | May 18, 2012 | Comments Off
“Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs…more“
EMA extends real-time release testing role in new guidelines
Posted on | April 17, 2012 | Comments Off
The EMA has released guidelines extending use of real-time release testing (RTRT) beyond terminally sterilised products…
http://www.in-pharmatechnologist.com/Processing-QC/EMA-extends-real-time-release-testing-role-in-new-guidelines
