Newsletter - May 24, 2018
Impossible Burger Shows How Impossible FDA’s Job Is When It Comes to Food
One of FDA’s key roles in regulating food is to determine if the ingredients used are GRAS (Generally Recognized As Safe). It also requires food manufacturers to seek approval for using new dietary ingredients (NDI). Although FDA also regulates other aspects of food, such as quality, food manufacturers do not need preapproval from FDA... Read More
Right-To-Try Does Not Change Drug Company-Patient Interactions for Test Drugs
Right-To-Try is all set to become the law and the only big change is the shift in the role of FDA from an approver to observer for compassionate use of investigational products. The impact on patient access is limited at best and it does help the drug companies who own such investigational products but eliminating the regulatory risk. Read more
Impossible Burger Shows How Impossible FDA’s Job Is When It Comes to Food
One of FDA’s key roles in regulating food is to determine if the ingredients used are GRAS (Generally Recognized As Safe). It also requires food manufacturers to seek approval for using new dietary ingredients (NDI). Although FDA also regulates other aspects of food, such as quality, food manufacturers do not need preapproval from FDA... Read More
Right-To-Try Does Not Change Drug Company-Patient Interactions for Test Drugs
Right-To-Try is all set to become the law and the only big change is the shift in the role of FDA from an approver to observer for compassionate use of investigational products. The impact on patient access is limited at best and it does help the drug companies who own such investigational products but eliminating the regulatory risk. Read more
