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# Modernization of FDA Drug Regulatory Program Outlined
- URL: https://www.fdaweb.com/modernization-of-fda-drug-regulatory-program-outlined/
- Published: 2019-08-23T12:00:00.000Z
- Updated: 2026-09-15T01:45:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144850

Attorneys **Khelin Aiken** and **Anisa Mohanty** (McDermott Will & Emery) review the FDA proposal to modernize new drug development as authorized by the 21st Century Cures Act. The agency’s 2018 initial proposal, they [write](https://www.lexology.com/library/detail.aspx?g=fc7a25bc-db6c-44c8-b681-842e5dde6d01&ref=fdaweb.com) in an online post, covered: 

- focusing on recruiting talent across disciplines;
- building multidisciplinary teams for more efficient collaboration;
- prioritizing operational excellence through a single and consistent review process;
- improving knowledge management through enhancements to information technology and honed expertise within review divisions;
- emphasizing safety and risk-benefit analysis before and after approval; and
- incorporating the patient voice into product development.

Recently, the attorneys write, FDA announced six strategic objectives that expound on the original 2018 proposal and continue throughout 2020\. They are: 

- scientific leadership;
- integrated assessment;
- benefit-risk monitoring;
- managing talent;
- operational excellence; and
- knowledge management.

The attorneys write that the agency also detailed six programs and projects currently underway that demonstrate its commitment to implementing the initiative: 

- a new integrated review process for drug marketing applications;
- IND review management;
- post-market safety management;
- assessing talent;
- optimizing administrative operations; and
- transition management and reorganization of the new drugs regulatory program.

According to the post, sponsors and applicants can expect faster approvals, largely in part due to FDA efforts to align expert staff with their respective therapeutic areas and to retain and increase talent via the Cures Act pay authority. Sponsors and applicants also can anticipate more certainty and greater transparency in product application reviews and should anticipate the need for increased communication with FDA throughout the approval process, it says.