Wednesday, September 16, 2009

FDA Says You Only Have 15 Days To Respond To Form 483

The cover of Federal Register.Image via Wikipedia

According to this PharmTech article, FDA Begins Enforcing Deadlines on Form 483 Responses, you have only 15 days to respond to a form 483.

Be aware, this article states:

Now, however, FDA “will not ordinarily delay the issuance of a warning
letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.

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