December 3, 2018
“As part of the FDA’s efforts to promote drug competition and increase patient access to high-quality, safe and affordable medicines, we’ve advanced many policies aimed at making it more efficient for companies to bring generic competition to the market. We’re focusing new efforts on policies aimed at making the generic development process more predictable and efficient to reduce the cost of developing generic drugs, and cut down on the number of applications that require multiple cycles of review before approval,” said FDA Commissioner Scott Gottlieb, M.D. “When an application requires multiple cycles of review before being approved, it delays patient access to medicines, and is resource intensive for the FDA and the generic sponsors. By giving generic developers more guidance on how to correct deficiencies in their applications, we believe we can reduce the number of generic drug applications that require multiple cycles of review. Over the next several months, the FDA will continue to advance guidance to assist industry in submitting complete applications that are ready for the agency’s review so more high-quality generics can get to patients.”
Today, the U.S. Food and Drug Administration finalized the guidance, Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA, which provides recommendations to industry on post-complete response letter (CRL) meetings between the FDA and generic drug applicants for the purpose of clarifying deficiencies identified in CRLs.
Efficient, consistent procedures are important for the timely and effective conduct of post-CRL meetings. The FDA is issuing this guidance to assist applicants in generating and submitting a request for a post-CRL meeting to the FDA as contemplated in the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II). This guidance is intended to provide procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the timeframes, or performance goals, set forth in the GDUFA II Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).
The agency is committed to providing robust information to generic drug applicants to help ensure that more high-quality and complete applications are submitted, which in turn allows for a more efficient review of these applications. New steps to improve the overall efficiency of the generic development process – and reduce the number of applications that require an additional cycle of review before approval – will be a significant focus of our additional policy efforts this coming year.
In furthering the agency’s commitment to providing robust information to generic drug companies to help ensure better and more complete applications are submitted to allow for a more efficient review, the FDA will also be issuing final guidance to assist applicants in determining which one of the abbreviated approval pathways is appropriate for the submission of a marketing application to the agency. The FDA will also be issuing draft guidance on the timing and content of amendments to tentatively approved abbreviated new drug applications to facilitate submission in a timely fashion to ensure final approval on the earliest lawful approval date.
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
Federal Register: Guidance: Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.