In an unprecedented policy shift, the FDA made public an initial set of over 200 complete response letters (CRLs) issued to drug sponsors between 2020 and 2024. These letters detail the agency’s reasoning for rejecting drug approval applications, although many are redacted to protect confidential information. The disclosures aim to increase transparency regarding common deficiencies cited by the FDA and offer sponsors and investors insight into regulatory decision-making. The released CRLs correspond only to drugs ultimately approved, representing a first step in broader openness.