FDA Study Data Validator Rules for Electronic Regulatory Submissions
FDA Validator Rules are technical criteria and guidelines applied by the U.S. FDA during regulatory submission review.
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- Aug 29
- 3 min
Five Challenges that Early-Stage Companies Should Consider When Planning for Their First IND
An Investigational New Drug (IND) application is a critical step for companies aiming to test their new drug candidates in humans....
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- Jul 12
- 4 min
Drug Development Designation for FDA Accelerated Approvals - Part 2
Part two of a series about FDA approvals. In Part 1, covered the approval framework. Part 2 covers accelerated approvals.
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- Jun 20
- 4 min
FDA Approvals: Understanding the Process and Designations for Safe and Effective Medications: Part 1
In the world of drug development, the Food and Drug Administration (FDA) approval holds immense significance. It represents a meticulous...
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- Apr 10
- 4 min
The FDA Electronic Submissions Gateway: Kicking Off the FDA Review Process
In today's fast-paced and technology-driven environment, ensuring the efficient exchange of information between regulatory agencies and...
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- Jan 9
- 5 min
Considerations When Evaluating eCTD Submission Publishing and Management Vendors
Getting your product’s regulatory submission ready to send to the FDA, Health Canada, or European health authorities can be...
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- Nov 15, 2022
- 5 min
PDUFA: 30 Years and Counting
The Prescription Drug User Fee Act (PDUFA) was signed into law in 1992 by George H. W. Bush, as an amendment to the Federal Food, Drug,...
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- Oct 6, 2022
- 4 min
Should Small Pharma and Biotech Companies Build Regulatory Operations Capabilities?
Small pharmaceutical and biotech companies that are preparing to submit their first Investigational New Drug Application (IND) must make...
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- Aug 15, 2022
- 4 min
FDA Resources to Support Your Next eCTD Submission
The U.S. FDA has published numerous resources that teams can access to understand the requirements for a submission in electronic Common...
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- Apr 28, 2022
- 4 min
Ad Promo Series: Using Grouped Submissions for Multi-Product Advertising Materials
Introduction In 2015, the concept of grouped submissions was introduced with the implementation of the US Module 1 specification v3.3....
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- Apr 18, 2022
- 1 min
Updates to the FDA’s Ad Promo Guidance
The FDA ad promo guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and...
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- Feb 21, 2022
- 1 min
eCTD Module 1 Specification Reminder
O March 1, 2022, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01)
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- Apr 6, 2021
- 5 min
The Basics of BIMO
Introduction If you have submitted an initial marketing application in the US over the past few years, you may have included a BIMO data...
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- Jul 22, 2020
- 3 min
FDA Ad-Promo Series: 2253 Submissions in eCTD Format
WAYS describes the documentation required for 2253 submissions in eCTD format
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- Apr 29, 2020
- 4 min
Compiling US Orphan Drug Designation Requests
In the United States, the Orphan Drug Act (ODA) was passed in 1983 to facilitate the development of drugs or biologics that are used for the
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- Mar 19, 2020
- 3 min
eCTD Guidance Updates – What’s New in 2020
FDA has released several updates to eCTD Guidances
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- Jan 23, 2020
- 5 min
Simultaneous US/EU Submissions: 5 Tips for Success
Introduction The US NDA and EU MAA applications are complex projects that take careful strategic planning and time management. The two...
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- Nov 4, 2019
- 6 min
Annual Registration Renewals: Ensuring Compliance to Avoid Inactivation
Every year, from October 1st to December 31st , sponsors are required to renew their Establishment Registrations with FDA, as well as...
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- Oct 24, 2019
- 3 min
Drug Master Files: Highlights of the Updated FDA Guidance
On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...
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- Oct 3, 2019
- 2 min
New Draft FDA Guidance: Electronic Format for Medical Device Submissions
On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...
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