Posted by Michael Wonder on 15 Sep 2021
FDA, EMA launch complex generic, hybrid product advice pilot
15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel scientific advice to sponsors of complex generic drugs, or hybrid medicines, as they are called in the EU.
FDA says the pilot is an expansion of the two agencies' existing parallel scientific advice programs for new drugs and biologics. The tenets for the pilot and details regarding the process and procedures are laid out in a joint general principles document released by both agencies.
