Only 5 Working Days Left in February, and Month Two of the Elemental Impurities Impact is Being Felt
As of this morning, there were only 20 full ANDA approvals and 2 tentative approvals listed on FDA All Approvals list (here). In contrast, there were 9 NDAs with full approvals and one tentative approval. Looks like ANDAs have been more impacted by the elemental impurities (EI) documentation requirement than it has for NDAs. I […]