Newsletter - February 20, 2020
FDA Has the Final Say for What Studies Are Needed for Approval
Last year, Vanda Pharmaceuticals sued FDA for putting its clinical trial on partial hold for lack of nonclinical data from dog studies. This week, a federal court ruled that FDA has the authority to ask for any additional data that FDA’s reviewers deem necessary to lift the clinical hold. Read More
Does FDA Allow Cockroaches and Rat Hair in Chocolate?
There is a video circulating on social media claiming that FDA allows significant amounts of filthy content in common foods such as cockroach parts, rat hair, and animal excreta in chocolate, mold and insect eggs in orange juice, insect larvae in corn, and so on. There is some truth in this statement...Read More
FDA Has the Final Say for What Studies Are Needed for Approval
Last year, Vanda Pharmaceuticals sued FDA for putting its clinical trial on partial hold for lack of nonclinical data from dog studies. This week, a federal court ruled that FDA has the authority to ask for any additional data that FDA’s reviewers deem necessary to lift the clinical hold. Read More
Does FDA Allow Cockroaches and Rat Hair in Chocolate?
There is a video circulating on social media claiming that FDA allows significant amounts of filthy content in common foods such as cockroach parts, rat hair, and animal excreta in chocolate, mold and insect eggs in orange juice, insect larvae in corn, and so on. There is some truth in this statement...Read More
