Law of the land can help or destroy the Pharmacovigilance system

U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects. Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their [...]

Harvard Medical Schools new automated safety surveillance system provides faster early warnings in the postmarket evaluation of medical device safety

Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents “Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical [...]

FDA has poor oversight in medical device monitoring and post market surveillance

According to a British Medical Journal, article on the effectiveness of post-market surveillance, medical device manufacturers “often fail to properly conduct safety studies” and the Food and Drug Administration (FDA) “provides scant oversight” in post-approval monitoring of these devices. The article is published by Jeanne Lenzer and Shannon Brownlee, called  “Why the FDA can’t protect [...]

Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems. In 2009, Health [...]

Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs

The Institute is focused on research that will accelerate IT innovation to advance personalized medicine and the delivery of safe and effective   treatments and health care services to patients around the globe. OHSI will work in tandem with academic research centers, focusing on a targeted set of research areas fundamental to the R&D and [...]

Multi National Pharma sell their Captive Clinical Research Facilities in India

MNC pharma companies to control 8% of $20bn worth Indian medicines market by 2015. According to a FICCI study more than 60% of trials in India is conducted by Global Big Pharma companies.  Indian Clinical Research arena is often compared to the Indian outsourcing success and hte wave of BPO industry success in India. Multi [...]

Oracle’s 3rd Annual Drug Development and Safety Forum 2009- India

Oracle’s 3rd Annual Drug Development and Safety Forum 2009 October 21 – 22, 2009 Oracle invites you to the 2009 Drug Development and Safety Forum At this forum we will be discussing important topics and issues facing the Indian Pharmaceutical Biotechnology, and CRO industry. This event will be highlighted by presentations from key industry thought [...]