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Blog

Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation

Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.

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Blog

Good Manufacturing Practices (cGMP): When Do They Apply?

When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:

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3 min. read
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