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Category Archives: Safety
US and Europe At Risk from Substandard Medicines
Guest blog by Helen Disney, Chief Executive and Founder of the Stockholm Network, a pan-European think tank.
When most of us look at taking a new medicine we tend to think it will make us better. Some of us may think about possible side effects but few of us expect the medicines we take to actually [...]
Also posted in Biotech, Emerging Markets, Europe, Global, Guest Blog, Regulatory Tagged biosimilars, Brazil, China, counterfeit medicines, developing nations, Emerging Markets, Europe, Indian, Regulatory, substandard medicines, Turkey, US Leave a comment
Adverse Event Reports Go Digital Only
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FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions.
“This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with [...]
UK: Swine Flu ‘Backlash’ Continues
Barely two weeks after the pricing and profit margins of Big Pharma’s swine flu vaccines and anti-virals were the subject of the critical spotlight in the UK media, Roche’s Tamiflu (oseltamivir) has come under scrutiny, fuelled by articles in the British Medical Journal (BMJ) and The Lancet Infectious Diseases questioning the drug’s effectiveness in young [...]
FDA Panel Calls for Ban on Narcotic/Tylenol Combo Drugs
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A joint committee of three FDA advisory groups voted on Tuesday to recommend the elimination of prescription combination drugs containing acetaminophen due to a spike in instances of liver-induced toxicity.
The panel of experts, physicians, and regulators voted 20 to 17 in favor of banning acetaminophen combo drugs such as Vicodin and Percocet. They [...]
Takeda Changes Dexlansoprazole Brand Name From Kapidex to Dexilant