Regulatory Sciences
FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements
Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...
Clinical Research Solutions
Pedaling While Fixing a Flat: Conducting a Good FDA Meeting Under Bad Circumstances
Before using a significant risk medical device in a clinical study, Sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and...
Clinical Research Solutions
Why It's Smarter to Play the Long Game When Planning Your FDA Submission
The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your...
Clinical Research Solutions
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
Clinical Research Solutions
FDA Draft Guidance on Tentatively Approved ANDA Submissions
FDA Draft Guidance on Tentatively Approved ANDA Submissions: On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22,...