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May 2009

Good and Bad Responses to 483s

Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action. This can allay FDA concerns about the firm's compliance, and reflect positively on the organization. If the response is poorly written, contains errors or omits critical information, it can trigger additional inspections or a Warning Letter. If the firm submits inadequate responses to a Warning Letter, the firm is at risk for seizures, suspension of product approvals, injunctive action or possibly criminal prosecution. While this article is focused on 483 responses, the recommendations apply equally to Warning Letters.

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SPL R4: The Latest on Electronic Regulatory Submissions

As of June 1st, 2009 the FDA will no longer accept Establishment Registrations or Product Listings submitted on paper for human prescription drugs, human over-the-counter drugs, or listed biologics and veterinary medicines. After that date, all such filings must be made electronically through the FDA's electronic submission gateway and encoded in XML, according to the rules set out in the HL7 Structured Product Labeling (SPL) standard and the FDA implementation guide. Medical devices are not currently included but are likely to be included in the future.

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Did you know that a regulatory authority can refuse to accept your drug or biologic submission for review if the files are not compliant with PDF file format requirements?

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