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Key Points
Audio Transcript
FDA's Unapproved Drugs Initiative is an integral part of our overarching commitment to drug safety.
Unapproved drugs pose significant concerns for public health, mainly because they have not been demonstrated to meet modern standards for safety, efficacy, quality, and labeling. The Unapproved Drugs Initiative is an effort to ensure that ALL marketed drugs adhere to those same modern standards.
By one estimate, two percent of all prescriptions written in this country are filled with unapproved drug products. Many over-the-counter drugs reaching retail shelves are also unapproved or fail to meet the requirements outlined in OTC monographs established by FDA. Since the Unapproved Drugs Initiative was announced in 2006, many companies have asked FDA how to get their unapproved products approved by the FDA.
Please explore this training to learn about the pathways to obtaining FDA approval for your products.
The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, manufacturing quality, and labeling. The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a drug product. For instance, an applicant must demonstrate that their manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. Further, FDA's review of the applicant's labeling ensures that health care professionals and patients have the information necessary to understand a drug product's risks and benefits, as well as how to use the drug safely and effectively.
Unapproved drugs that are marketed challenge the integrity and authority of the prescription and OTC drug approval system. For one, these products reduce incentives for other companies to conduct research to prove safety and effectiveness of their compound. By failing to go through the approval process, unapproved drugs compete unfairly with approved drugs or drugs covered by a finalized OTC monograph.