This week at Asphalion, we’re highlighting key regulatory topics as part of our Regulatory Operations eSub-Week series. Today, the spotlight is on the FDA.
To help you navigate the U.S. regulatory landscape, we have developed a compilation of informational flyers on FDA eSubmissions, covering the following key topics:
- Investigational New Drug (IND) applications: Guidance on exemptions required for transporting investigational drugs across state lines and initiating clinical studies.
- FDA Adverse Event Reporting System (FAERS): Understanding the database of adverse event reports, medication errors, and product quality complaints submitted to the FDA.
- Structured Product Labeling (SPL): Overview of this HL7-developed standard, adopted by the FDA for exchanging product and facility information using XML.
- FDA Study Data (ada. DATASETS): Insights into FDA requirements for structured study data submissions.
At Asphalion, we are committed to guiding you through every step of the regulatory pathway. Our eSubmission team supports the full FDA regulatory process, including dossier preparation, eCTD publishing, SPL and dataset creation, adverse event reporting, and US agent support.
Explore these topics in more detail by viewing our brochure, and reach out with any questions: FDA eSubmissions
Contact us for more information or regulatory support: [email protected]
