Draft Guide on New ANDA Review Letters

FDA has issued a draft guidance on “Information Requests and Discipline Review Letters Under GDUFA” that outlines how such letters will be used during the ANDA review process. The recently reauthorized generic drug user fee program calls for using the letters to provide “preliminary thoughts on possible deficiencies as each review discipline finishes its initial review of its portion of the received application,” the guidance says. Around the mid-point of the review clock, FDA will send either an information request or a discipline review letter to “improve FDA’s predictability and transparency, promote the efficiency and effectiveness of FDA’s review process, minimize the number of review cycles necessary for approval, increase FDA’s overall rate of approval, and facilitate greater access to generic drug products,” it says. The guidance also urges applicants to submit high quality, complete submissions.