FDA submissions – FDA Guidelines and catalogue
09/20/2021
Category: Other Blogs
Whenever a new molecule or a generic drug has to be sold in the market, it first needs to be registered with...
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New drug application (NDA) in today’s world
09/16/2021
Category: Other Blogs
In the United States, a board named the Food and Drug Administration, commonly known as FDA, handles the New drug Application (NDA)....
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How to know if an IDE is required?
09/11/2021
Category: Other Blogs
An IDE or Investigational Device Exemption is typically an approval mechanism via FDA to investigate high-risk medical devices. The data you generate...
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GTP Final Rule for HCT/Ps and its purpose and process
09/09/2021
Category: Other Blogs
Those who manufacture human-cell, tissue, and cellular-based products for the FDA have fixed the current good tissue practice. This rule is very...
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