How is pharmaceutical labeling regulated?

Before a company is able to legally sell a new drug, it must submit an application to the FDA (U.S. Food & Drug Administration). This process regulates the medicine that is supplied by medical professionals and applications detail whether a new proposed addition to the market is safe to use and effective for its proposed use. All applications must be backed up by data and medical trials to prove their claims and the FDA provides a range of labeling resources that can be used to guide applications in the right direction. To ensure the thorough testing of a new drug label before it is able to reach patients, the review is typically conducted by doctors with a specialty in the condition being treated, clinical pharmacology staff, labeling specialists, regulatory project managers, safety experts, statisticians, and more. 

Before submitting an application to the FDA, a pharmaceutical company must ensure their labels have been created in line with the official resources and once a proposal is ready to send, the submission should be supported with medical trials and scientific data. This information will be reviewed by the FDA which will come back with any potential issues which must be resolved before the process can continue. Throughout the review, the FDA team will need to be assured that the backup supplied is sufficient and be satisfied that the pharmaceutical labels accurately represent the contents of the drug. If they discover inaccurate data, misleading language, or a lack of information, the FDA review team is likely to ask for additional data to clarify statements before the product can be approved.

Once the label has been approved at the first stage, it will then be sent onwards to the FDA’s Center for Drug Evaluation and Research and the FDA’s Center of Biologics Evaluation and Research to carry out further reviews. After this stage, the drug company is legally permitted to submit Structured Product Labeling. This means electronic versions of the label can be posted onto the internet and viewed by the public within 14 days of approval.


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