Demanding precaution be added to package insert

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Reference no: EM133639612

The FDA has identified a safety signal with your 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.

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

1. What would be part of this correspondence that would allow the FDA to feel comfortable that the precaution is not needed?

2. What data would be presented to support the company position?

3. Is there any literature references which support the company position?

- 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?

- 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?

- What other ways could a company respond to such a recommendation?

Reference no: EM133639612

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