FDA Study Data Validator Rules for Electronic Regulatory Submissions




- Aug 29
- 3 min
Five Challenges that Early-Stage Companies Should Consider When Planning for Their First IND


- Jul 12
- 4 min
Drug Development Designation for FDA Accelerated Approvals - Part 2


- Jun 20
- 4 min
FDA Approvals: Understanding the Process and Designations for Safe and Effective Medications: Part 1


- Apr 10
- 4 min
The FDA Electronic Submissions Gateway: Kicking Off the FDA Review Process


- Jan 9
- 5 min
Considerations When Evaluating eCTD Submission Publishing and Management Vendors

- Nov 15, 2022
- 5 min
PDUFA: 30 Years and Counting


- Oct 6, 2022
- 4 min
Should Small Pharma and Biotech Companies Build Regulatory Operations Capabilities?


- Aug 15, 2022
- 4 min
FDA Resources to Support Your Next eCTD Submission

- Apr 28, 2022
- 4 min
Ad Promo Series: Using Grouped Submissions for Multi-Product Advertising Materials


- Apr 18, 2022
- 1 min
Updates to the FDA’s Ad Promo Guidance


- Feb 21, 2022
- 1 min
eCTD Module 1 Specification Reminder


- Apr 6, 2021
- 5 min
The Basics of BIMO

- Jul 22, 2020
- 3 min
FDA Ad-Promo Series: 2253 Submissions in eCTD Format

- Apr 29, 2020
- 4 min
Compiling US Orphan Drug Designation Requests

- Mar 19, 2020
- 3 min
eCTD Guidance Updates – What’s New in 2020

- Jan 23, 2020
- 5 min
Simultaneous US/EU Submissions: 5 Tips for Success

- Nov 4, 2019
- 6 min
Annual Registration Renewals: Ensuring Compliance to Avoid Inactivation

- Oct 24, 2019
- 3 min
Drug Master Files: Highlights of the Updated FDA Guidance

- Oct 3, 2019
- 2 min
New Draft FDA Guidance: Electronic Format for Medical Device Submissions