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FDA Blog

Hand Sanitizer consulting

Coronavirus transmission: how to protect yourself from coronavirus?

By

  05/26/2020

  Category: Other Blogs

Coronaviruses are a family of viruses that can be pathogenic for humans and animals. In humans, several coronaviruses are known to cause...

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FDA pre-submission program

Device Details: FDA Pre-submission programs and in vitro diagnostics

By Kelly Shelton

  05/19/2020

  Category: Other Blogs

Medical devices are essential tools for human medicine. They are intended, by their manufacturer, to be used with medical advice/administration and provide...

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Drug Post Launch Activity

Post Launch Activity – How is a new drug developed and tested, even after approval? Know the end-to-end process

By Kelly Shelton

  05/12/2020

  Category: Other Blogs

This is a question that many of us, as patients or family members of people with rare diseases in particular, ask ourselves....

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medical device expert

510(k): How to evaluate the needs for medical device compliance?

By Kelly Shelton

  05/07/2020

  Category: Other Blogs

The techniques and methods used in device evaluations depend on the type of specific product. Devices are diverse in nature in components...

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Global Experts in biotechresearchgroup

IND consulting and regulations

By Kelly Shelton

  05/02/2020

  Category: Other Blogs

During the development of a new drug, a sponsor should determine whether the product is safe for early use in humans and...

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