Newsletter - November 3, 2016
Multinational Expedited Approval Pathways
Promising treatments are provided preferential review options in several regulatory domains. This week Australia’s Therapeutic Goods Administration (TGA) joined regulators in US, Canada and Europe in creating two expedited approval pathways for promising drugs, namely, the Priority Review and Provisional Approval designations. The Priority Review process is similar to that at the FDA where the eligible application will be reviewed in a shorter time.. Read More
Biased Clinical Trial Results
Bias in clinical trial results is often suspected, particularly when the studies are not independently reviewed by regulators. Clinical studies are often conducted for marketing purposes with non-FDA regulated products such as food and supplements. In a review of clinical studies conducted to evaluate the link between consumption of soda and occurrence of obesity, it was found that all the studies funded by the soda manufacturers.. Read More
Multinational Expedited Approval Pathways
Promising treatments are provided preferential review options in several regulatory domains. This week Australia’s Therapeutic Goods Administration (TGA) joined regulators in US, Canada and Europe in creating two expedited approval pathways for promising drugs, namely, the Priority Review and Provisional Approval designations. The Priority Review process is similar to that at the FDA where the eligible application will be reviewed in a shorter time.. Read More
Biased Clinical Trial Results
Bias in clinical trial results is often suspected, particularly when the studies are not independently reviewed by regulators. Clinical studies are often conducted for marketing purposes with non-FDA regulated products such as food and supplements. In a review of clinical studies conducted to evaluate the link between consumption of soda and occurrence of obesity, it was found that all the studies funded by the soda manufacturers.. Read More
