Newsletter - October 1, 2020
FDA Tightens ANDA Review and Rejection Timelines
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 the deficiencies with a goal to eliminate arbitrary repeated extension....Read More
FDA’s Food Traceability Rule to Track Food from Farm to Table
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). Read More
FDA Tightens ANDA Review and Rejection Timelines
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 the deficiencies with a goal to eliminate arbitrary repeated extension....Read More
FDA’s Food Traceability Rule to Track Food from Farm to Table
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). Read More
