Day: October 1, 2020

Last week FDA proposed new rules for food traceability that would require manufacturers, processors, packers, storage companies and distributors to maintain detailed records regarding growing, receiving, creating, transforming and shipping certain foods on the newly created Food Traceability List (FTL). The goal of these rules is to allow rapid mitigation of food borne illness outbreaks … Read more

Soon ANDA applications for generic drugs will not be able to go through multiple review cycles due to the applicants taking too long to respond to the deficiencies identified by FDA. This week FDA released a new guidance that sets strict timeline of 1 year to respond to deficiencies with a goal to eliminate arbitrary … Read more