Regulatory Sciences
Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions
For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....
Biotech Startup Approaching IND: 5 Mistakes to Avoid While Writing a Development Plan
In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...
What You Need to Know About CBER Pre-IND Meetings
The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...
Regulatory Sciences
6 Compliance Tips to get FDA Approval for Your Pharmaceutical Project
FDA Approval Process Overview The Food and Drug Administration (FDA), as part of the United States (US) Department of Health and Human Services, is the regulatory agency responsible for the review,...
FDA Sets A Deadline For Electronic Submission Of Drug Applications
In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...