Posted On: August 14, 2024
Ensuring drug safety is vital, and the Emerging Drug Safety Technology Program (EDSTP) is leading the way.
In the past, monitoring drug safety was tough. It involved a lot of paperwork and managing vast amounts of data on adverse drug reactions.
Now, new technologies like artificial intelligence are making a big difference. These advanced tools can automate tasks such as data intake, entry, and processing. This reduces administrative work and costs while making it easier to track drug safety.
With AI, we can handle and analyze much larger and more varied sets of data.
The Emerging Drug Safety Technology Program (EDSTP) is an innovative initiative focused on integrating artificial intelligence (AI) and other emerging technologies into pharmacovigilance (PV). PV emphasizes keeping an eye on drug safety after they hit the market.
Started by the Center for Drug Evaluation and Research (CDER), this program strives to make sure drugs stay safe throughout their lifecycle.
The EDSTP has three primary goals:
To reach these goals, the CDER has put together the Emerging Drug Safety Technology Meeting (EDSTM) program.
These meetings pave the way for open conversations, helping the FDA get a better grasp of how AI tools are being used in pharmacovigilance (PV).
To participate in the EDSTM program, applicants and other relevant parties must meet specific eligibility criteria:
If your business holds an approved application regulated by the CDER, you are eligible to request an Emerging Drug Safety Technology Meeting (EDSTM).
This covers -
Application Types | Descriptions |
New Drug Applications (NDAs) | Applications for innovative drugs | Applications for innovative drugs that have been thoroughly reviewed by FDA. |
Abbreviated New Drug Applications (ANDAs) | Applications for generic versions of already approved drugs. |
Biologics License Applications (BLAs) | Applications for approval to market biologic products, such as vaccines and gene therapies. |
Simply put, if your business has received approval for any of these types of drug applications, you can participate in an EDSTM.
Entities that support the industry's PV activities can also apply. This includes, but is not limited to, academia, Contract Research Organizations (CROs), pharmacovigilance vendors, and software developers.
These organizations are integral in developing or leveraging AI and other technologies to meet post-marketing reporting requirements.
Eligible technologies should be geared toward post-market PV activities. While some technologies may be useful for both pre- and post-market PV, the EDSTM program explicitly focuses on post-marketing surveillance.
The regulatory requirements that these technologies aim to comply with include 21 CFR 314.80, 314.98, and 600.80, which outline the standards for postmarketing reporting.
The program allows not only individual applicants to request meetings but also facilitates joint applications.
For example, an applicant and their PV vendor could jointly request an EDSTM. This cooperative approach could lead to more comprehensive and insightful discussions.
The EDSTM program offers great opportunities to integrate the latest technologies into post-market drug safety monitoring, making the medicines safe for everyone.
Whether you hold an approved application, or if you're a relevant party involved in pharmacovigilance activities, participating in the EDSTM program can help you leverage technology for better public health outcomes.
The EDSTP is an initiative focused on adopting innovative tools and ways to make sure drugs are safe. It aims at improving how we monitor medications in real-time to ensure drug safety.
Applying for the EDSTP is pretty straightforward. You need to fill out an application on the program’s website. Provide accurate details about your current projects, your tech capabilities, and how you plan to help improve drug safety. Just make sure to go through the eligibility criteria and application requirements carefully before hitting submit.
Understanding the Difference Between Authorized and Unauthorized Pharmacy Distributors
DSCSA and GS1: How These Regulations Are Transforming Pharmaceutical Distribution
A Beginner's Guide to GS1 Standards for Pharmaceutical Companies
What are Important Accomplishments of the NDRP Modernization
A Comprehensive Guide to Prescription Animal Drugs
DSCSA and GS1: How These Regulations Are Transforming Pharmaceutical Distribution
A Beginner's Guide to GS1 Standards for Pharmaceutical Companies
What are Important Accomplishments of the NDRP Modernization
New Drugs Regulatory Program Modernization: Overview and Impact
DSCSA Compliance For Dispensers/Pharmacies