Tag: fda ORA

FDLI Annual 2025

Posted on by Brandon Miller

Join Regulatory Compliance Associates (RCA) in Washington, DC May 15th-16th for the FDLI Annual Conference to connect with our consulting Experts to learn how we can provide you with a complete solution for any of your projects. Together we can confidentially discuss your client and can prepare compliance enforcement solutions to help ensure the safety of their products, process, and organization as a whole.

Conference Highlights:

  • Hear FDA’s strategic priorities directly from the FDA Commissioner and other key leaders within the agency and Health and Human Services
  • Join high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding
  • Participate in over 30 sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues to enjoy targeted for your key interests
  • Learn from more than 100 well-known officials and experts
  • Hear about the Top Cases in Food and Drug Law
  • Network and build relationships with seasoned legal, regulatory, compliance, policy, and government professionals

About the FDLI Annual Conference

Looking forward to seeing you at the 2025 FDLI Annual Conference, the premier event for the food and drug law community! Our conference provides a unique opportunity to delve into the complex legal, regulatory, compliance, and policy issues currently impacting FDA-regulated industry. Join experts from federal government, industry, the private bar, non-profit organizations, patient and consumer advocacy groups, consulting organizations, and academia as the FDLI community meets for the event of the year!
 

Register Now

 

Food And Drug Administration

Posted on by Brandon Miller

The Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, recently testified in front of a Senate Appropriations subcommittee about core programs for the 2025 budget process. Executives at FDA are asking for a $341 million increase in the annual budget (currently proposed at $7.22 billion) compared to the previously approved FY 2024 budget.

 

Drug Shortage

 

One topic that received significant interest was drug shortages. Dr. Califf confirmed there are still over 200 drugs classified as in shortage. FDA has requested over $12 million to help rectify the problem and bring greater predictability to supply chain problems. Additionally, the ability to clarify pharmaceutical manufacturing problems that may arise appears to be a priority to FDA.

 

Regulatory Affairs

 

The Office of Regulatory Affairs (FDA ORA) has asked for an additional $2.7 million to be added to the proposed budget. Specifically, ten new full-time employees are proposed as headcount to address issues with both drug shortages and problems inside the supply chain. $3 million is specifically proposed to recruit new FDA inspection resources who can help identify these types of scenarios in advance during routine FDA inspections.

 

Further, continued growth in regulatory applications for both medical device manufacturing and biologic manufacturing facilities was mentioned as critical to keep pace with the industry’s need for FDA approval inspections. For life science industry employees, the slowdown in FDA inspections has had mixed reactions.

 

Michael Rogers, associate commissioner for regulatory affairs at the FDA’s Office of Regulatory Affairs, has also recently commented about the need for more FDA auditors due to investigators who have recently retired. According to Rogers, FDA investigators “have been underrecognized and underappreciated”, which may have led to attrition over time at the agency.

 

Avian Influenza Virus

 

Dr. Califf continued the discussion with lawmakers about the potential dangers of avian influenza (or bird flu) and vaccine production. Commentary revolved around how prepared the United States government is in responding to virus mutations if bird flu could spread to humans. Further, Dr. Califf elaborated on how investments in personal protective equipment (PPE) & funding for vaccine manufacturing could help the potential problem.

 

Finally, short-term solutions focused on the safety of dairy workers if the virus infected the U.S. milk supply, and new research options to study how quickly the avian influenza virus may evolve. 

 

IT Infrastructure

 

Finally, FDA has requested over $8 million to improve critical infrastructure and upgrade technology across the agency. The goal is to modernize many of the legacy workflows the regulatory agency uses and increase the analytical potential of data analysis.

 

The entire presentation can be found at this link. 

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.