Tag: PMTA requirements
The FDA is Under Fire For Failing to Finalize PMTA Applications
The FDA has been rejecting PMTAs by the millions. Back in August 2021, the FDA announced that it would not even review 4.5 million...
The FDA Finalizes Two Rules for PMTAs
These rules are meant to ensure that all future submissions contain the basic information needed to meet the relevant premarket requirements efficiently and effectively.The...
