What regulations govern pharmaceutical labeling?

To govern the safe and effective use of the drug, the FDA (U.S. Food & Drug Administration) provide a wide range of labeling resources that relate to human prescription drugs and the safe development of their labeling. 

Before a company can legally sell or supply a drug, it must submit an application that details whether its medicine is safe to use and effective for its proposed use, backed up by data to prove its claims. Before applying to the FDA, questions are likely to be asked by a company to ensure that the proposal aligns with the regulations, ensuring they are on the right track before carrying out research studies or medical trials.

Once a proposal is ready to send, the drug company must make its application which includes prescribing information and data to support the safety and effectiveness of the product. This will be reviewed by the FDA and any potential labeling issues will be identified and required to be addressed before the process can continue and approval can be granted. The review is typically conducted by doctors with a specialty in the condition being treated, clinical pharmacology staff, labeling specialists, pharmacology/toxicology staff, product quality reviewers, promotional content specialists, regulatory project managers, safety experts, statisticians, a cross-discipline team leader, and division management.

During the review, the FDA team will be looking for confirmation that the information provided is scientifically accurate, that the product meets regulatory requirements, that the pharmaceutical labeling is informative and accurate, and that the wording is neither promotional nor misleading. Before approval, the FDA review team is likely to ask for additional data to support or clarify statements. 

Upon initial approval of the application, the approval of the following parties is also required before final approval is granted:

  • FDA’s Center for Drug Evaluation and Research 
  • FDA’s Center of Biologics Evaluation and Research 

Once all necessary reviews have been carried out, the drug company will submit Structured Product Labeling to FDA’s electronic listing system within 14 days of approval, allowing the electronic versions of the label to be posted to websites.


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