FDA Initiative For Innovative Clinical Trial Designs To Expedite Product Approval 

This week FDA announced a new initiative to encourage disruptive clinical trial designs aiming to expedite market approval of promising drugs and biologics. Several of these trial designs have been proposed in the recent years, mostly for products intended to treat cancers. The new initiative, called Complex Innovative Trial Design (CID) expands innovative trial designs … Read more

FDA’s Warns Online Pharmacies Selling Drugs Illegally Highlighting Challenges to Enforcement

Yesterday FDA announced that earlier this month it issued Warning Letters to four networks selling opioid drugs illegally online via 21 websites. Earlier this summer FDA had issued similar Warning letters to a total of 13 companies marketing opioid drugs illegally on about 70 websites. It is questionable if these measures are an effective deterrence … Read more