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Demanding precaution be added to Package Insert

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The FDA has identified a safety signal with Trikafta drug product and is demanding a precaution be added to the Package Insert. Upon receiving a copy of the data the FDA had reviewed to conclude that a new precaution is required, the Pharmacovigilance department at your company does not agree the signal is causally related.

Provide a response to the FDA with evidence that shows the addition of a precaution to the Package Insert is not warranted.

- What would be part of this correspondence that would allow the FDA to feel comfortable that the precaution is not needed for Trikafta drug?

- What data would be presented to support the company position for Trikafta drug?

- Is there any literature references which support the company position for Trikafta drug?

Additionally answer the following -

1. Do you think that once the FDA identifies a potential safety concern that they would back off from mandating a revision to the Package Insert? Why or Why not?

2. Do you believe that responding to defend the company position is a good strategy or would it be better to concede to the Agency opinion? Why or why not?

3. What other ways could a company respond to such a recommendation?

Reference no: EM133504536

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