Important Considerations and Benefits of Pre-IND Meeting
12/16/2020
Category: Other Blogs
After making a lot of plans and strategies, you are ready to start testing your drug in humans, but be confident that...
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Know about the Pre- Submission Meeting
12/11/2020
Category: Other Blogs
Pre-submission meeting refers to a structured process in order to manage and track interactions between the manufacturer and the FDA regarding future...
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Know about the types of FDA Drug Master File and its review and benefits
12/06/2020
Category: Other Blogs
A Drug Master File (DMF) is a document submitted to the FDA that includes a large amount of potentially confidential information about...
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Types of Q Sub Meeting Submission of FDA
12/04/2020
Category: Other Blogs
The FDA published the guidance document Medical Device Submission Feedback and Meeting Requests: Q Submission Program in 2019, but it took the...
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Know about the FDA De Novo Classification
12/02/2020
Category: Other Blogs
Recent changes to the Food and Drug Administration Modernization Act of 1997 have made it easier to review and approve new devices....
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