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Frequently Asked Questions and Answers on Notice of compliance (NOC) database.

What is the Notice of Compliance (NOC) Data Extract?
The data extract is a series of compressed ASCII text files of the database. The uncompressed size of the files is approximately 28.5 MB. In order to utilize the data, the file must be loaded into an existing database or information system.

This guidance helps to classify safety and efficacy changes made to new drugs that have received a Notice of Compliance (NOC) pursuant to section C.08.004 of the Food and Drug Regulations (the Regulations).

This section highlights the range in categories of data and contextual information that may be relevant to the evaluation of a particular submission.

This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples are not exhaustive and are meant to provide guidance on types of acceptable changes.

Notice of Compliance with Conditions - Qualifying Notice.

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information.

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice.