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Monday, 07/13/2020 11:48:16 AM

Monday, July 13, 2020 11:48:16 AM

Post# of 233474
Few things can be more damaging to a pharmaceutical company than the refusal by the Food and Drug Administration (FDA) to review their New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). When a company submits their application for authorization to market a new or generic drug and receives a Refusal to File (RTF) or Refusal to Receive (RTR) letter from the FDA, the damage to the company’s credibility and finances can be irredeemable. The irony is that such a situation is most often completely avoidable.

https://camargopharma.com/resources/blog/unforced-errors-fda-refusal-file-receive-letters/#:~:text=UNFORCED%20ERRORS%3A%20FDA%20Refusal%20to%20File%20or%20Receive,damage%20to%20the%20company%E2%80%99s%20credibility%20and%20finances%20
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