What are the labeling requirements for drugs in the US?

Introducing a new drug into the market is not an overnight process and requires lengthy market research, scientific data, and medical trials before it can be considered for use. Since the pharmaceutical industry is heavily regulated, the labeling of medication is a big factor in the success of a new product and packaging must be created by industry laws.

The FDA (U.S. Food & Drug Administration) is the governing body that regulates new additions to the drug market and provides a range of labeling resources to ensure that all providers are using the same guidelines, creating a nationwide standardization in the industry. Applying to all human prescription drugs, a company must apply before they are legally permitted to sell or supply a drug. Any claims made by a product must be backed up by data and supported by medical trials, ensuring that the proposal aligns with the regulations before it can be considered for public use. This will be reviewed by the FDA and will raise any potential issues with the pharmaceutical labeling that must be addressed before the product can continue through the approval process.

During the review, the label will be checked against a set of criteria to ensure that it is informative, accurate, and provides clear instructions to the patient. Any wording that could be considered promotional or misleading will be rejected and if a statement is unclear, the FDA is likely to request additional data to support the claim. To ensure the process is thorough, an FDA assessment will be carried out by various parties to gain a well-rounded review, including professionals such as 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. Once initial approval has been granted, a further review from both FDA’s Center for Drug Evaluation and Research and the FDA’s Center of Biologics Evaluation and Research is also necessary before granting final approval. 

Once a pharmaceutical label has been approved and is permitted to be sold in the US, a drug company can submit Structured Product Labeling to FDA’s electronic listing system after  14 days of approval, allowing an electronic version of the label to be viewed by the public.


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