“Complete Response” Letters
This article was originally published in Pharmaceutical Approvals Monthly
FDA stopped issuing “approvable” and “not approvable” letters in favor of “complete response” letters on Aug. 11, 2008. The following chart lists “complete response” actions recently announced, as well as still-pending “approvable” and “not approvable” actions.
You may also be interested in...
HBW editors Tom Gallen and David Ridley discuss the big issues in the European consumer health market from the past week. In this edition, they delve into probiotics, digital health and Bayer’s recent turnaround.
EU trade expert Hervé Jouanjean considers the reasoning behind the EU’s vaccine procurement approach and Italy's decision to block exports of AstraZeneca's COVID-19 vaccine.
Efforts are underway to create a harmonized approach among Persons Responsible for Regulatory Compliance who play a pivotal role in meeting the requirements of the EU MDR and IVDR. And liability issues are high on the agenda.