Drug Competition Action Plan: FDA Issues One Draft, One Final Guidance

With an eye toward reducing review cycles for abbreviated new drug applications (ANDAs) and better informing industry of the roles and responsibilities of US Food and Drug Administration (FDA) review staff, FDA on Monday released one draft guidance and one final guidance.

“As part of our ongoing efforts to lower drug prices and improve access to innovative medicines, the FDA is issuing two guidance documents to assist both FDA staff and industry in ensuring that the new drug review process and the generic drug review process is managed in a consistent, transparent and efficient manner,”
FDA Commissioner Scott Gottlieb said, noting the guidances are part of the FDA’s Drug Competition Action Plan.

Draft Guidance

The 8-page draft guidance discusses the roles and responsibilities of FDA review staff in managing the review process and identifies ways in which applicants may support an efficient new drug or biologic application review process with good review management principles and practices (GRMPs).

“The goal of GRMPs is to ensure that the review process is managed in a consistent and efficient manner, thereby decreasing the number of review cycles necessary for approval and enhancing patients’ timely access to important therapies,” the draft says.

The draft features sections on fundamental values (including accountability, communication and consistency), operational principles (“timely and frequent review team collaboration is critical to good review management”) and more on the new product review process.

This draft guidance revises the guidance for review staff and industry entitled “Good Review Management Principles and Practices for PDUFA Products” issued in April 2005, which FDA committed to updating as part of the Prescription Drug User Fee Act (PDUFA) VI and Biosimilar User Fee Act (BsUFA) II.

Final Guidance

While noting that, historically, it’s taken about four cycles of review for an ANDA to reach approval, Gottlieb said this final guidance is meant to “reduce application cycling by clarifying for industry how they can submit complete, high quality applications from the start.”

The 32-page guidance, finalizing a draft from June 2014, details the information that should be provided in each section of the common technical document format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations from FDA to assist applicants in preparing ANDA submissions.

“FDA is committed to providing comprehensive assistance in the early stages of the application process so that an ANDA will contain all information necessary for FDA to complete its review in one review cycle,” the guidance says.

Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications Guidance for Industry and Review Staff Good Review Practice: DRAFT GUIDANCE

ANDA Submissions — Content and Format: Guidance for Industry