The FDA Changes the Drug Approval Process

CDER is modernizing the process for reviewing NDAs and BLAs over the next two years.


The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) will be implementing six initiatives intended to modernize the review process for new drug applications (NDAs) and biologic license applications (BLAs) over the next two years.


The six ongoing initiatives were outlined by CDER Director Janet Woodcock at the FDA’s Food and Drug Law Institute annual conference. They are focused on integrated reviews for marketing applications, IND application review management, post-market safety management, assessing talent, reorganization management and administrative operations.


A streamlined interdisciplinary review process is already being phased in, with all CDER divisions using integrated reviews by the beginning of 2020. The goal is to reduce redundancy and enable better knowledge sharing and management. A new tracking tool will allow the tracking of review issues from the pre-NDA stage through the end of the review cycle. Two new roles are also being created - Clinical Data Scientists to support safety analysis and Medical Editors, to provide editing and formatting services, which are intended to allow reviewers to focus on science and regulatory aspects. Various meetings involving leadership and different divisions will also be held to address specific issues.


In addition, IND reviews going forward will include “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,” according to Woodcock. CDER is also developing a standardized post-market drug safety framework with cross-disciplinary, collaborative and science-focused assessments.


For generics, CDER will be publishing guidance documents on the Orange Book, therapeutic equivalence and Hatch-Waxman exclusivity, while for biosimilars, a final guidance on interchangeability and draft guidance on comparative analytical assessments are expected in May 2019.


The FDA will also be updating the Purple Book and reevaluating regulations related to the submission and review of BLAs. The 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,” according to Woodcock.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.