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FDA Blog

FDA submissions

FDA submissions – FDA Guidelines and catalogue

By Harry

  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

New drug application (NDA) in today’s world

By Harry

  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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Pre IDE

How to know if an IDE is required?

By Harry

  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 consulting

GTP Final Rule for HCT/Ps and its purpose and process

By Harry

  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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