A modernization of the way the US Food and Drug Administration (FDA) reviews new drug applications (NDAs) and biologic license applications (BLAs) will be instituted over the next two years, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock told attendees of the Food and Drug Law Institute’s annual conference on Thursday.
Six active initiatives related to this modernization are ongoing at CDER, including initiatives focused on integrated reviews for marketing applications, investigational new drug (IND) application review management, post-market safety management, assessing talent (Woodcock said CDER is still under-staffed), reorganization management and administrative operations.
The new integrated reviews, which are currently being phased in and will be used among all CDER divisions beginning in 2020, involve developing a streamlined interdisciplinary review process and template for assessing NDAs and BLAs.
The template and process will be issue-based and foster interdisciplinary collaboration, in addition to reducing redundancy and low-value work, and enabling better knowledge management, Woodcock said.
The modernization will also include the development of a tracking tool to be utilized from pre-NDA through the end of the review cycle, allowing for the systematic tracking of review issues for the entire review team.
CDER will also add two new roles to allow reviewers to focus on the science and regulatory aspects of the application: “(1) Clinical Data Scientists to support safety analysis and (2) Medical Editors to provide editing and formatting services,” a Woodcock slide notes.
The modernization will allow for working meetings with early involvement of leadership to discuss known benefit and risk issues, as well as joint assessment meetings focused on specific review issues.
In terms of IND management review changes, which will begin this summer, according to Woodcock, they will involve developing “a risk-based approach to categorize incoming protocols and amendments and identify the protocols that should follow a higher priority process to review more expeditiously.”
And next fall, CDER will work to create a standardized post-market drug safety framework with cross-disciplinary, collaborative and science-focused assessments.
Generics and Biosimilars
As far as upcoming actions related to generic drugs, CDER is planning guidance documents on the Orange Book, therapeutic equivalence and Hatch-Waxman exclusivity.
On the biosimilar end, final interchangeability guidance is expected by 17 May, while revised draft guidance on comparative analytical assessments is expected by 21 May.
An update to FDA’s Purple Book is also expected, as is a re-evaluation of FDA’ regulations regarding the submission and review of BLAs “to ensure that they account for current practices and authorities.”
“Updated regulations will provide enhanced clarity and regulatory certainty to manufacturers of both originator and biosimilar/interchangeable products, and will help prevent ‘gaming’ that could prevent or delay competition,” Woodcock said.