The Benefits and Risks Compared to the Traditional Route of Drug Approval

Paper Type: 
Pages:  3
Wordcount:  580 Words
Date:  2021-03-19

According to the U.S Department of Health and Human Services (2011), the TEA (Time and Extent Application) is used to determine if a drug has been marketed for a period over the counter (OTC). It is information that can be submitted by any interested party to have the conditions included in the monograph. In a nutshell, the TEA should consist of relevant information that is needed to establish if the drug or condition is eligible to be included in the drug monograph system. The OTC drug review in the U.S commenced in 1972 and before this there only existed traditional routes of drug approvals. However, publishing of these conditions took place in 2002. The conventional route of drug approval such as citizen petition and Federal Food, Drug, and Cosmetic Act required the applicant or company to obtain a premarket approval under Section 505. As compared to the TEA process, the overall benefit is that TEA requires the submission to demonstrate the recognition of safety and effectiveness. For example, the step two of the process places the TEA on public display to provide interested parties not only the applicant to meet the eligibility criteria. Other benefits of TEA in drug approval include preventing unnecessary costs to incur and avoiding expending FDA resources during the evaluation. Nonetheless, the conventional FD&C Act also has an imperative benefit over the TEA, which includes less or shorter time for review and approval of the application. Despite the risks that come with the time and extent application such as lack of confidentiality and longer review process of up to one year, TEA route of drug approval remains the safest and effective way of evaluating a condition under the OTC drug monograph system.

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Question 2

Benefits of Public Notice for OTC Drugs

The public notice or display is the second step process after the applicant submits the time and extent application. As earlier mentioned, the TEA is placed on public display as an appropriate method and efficient way to determine if a condition should be included in the drug monograph. One benefit of the public notice is that it provides all interested individuals or parties and not just the applicant an opportunity to submit the data and information safely and effectively. As the Food and Drug Administration explains, any interested person would have an opportunity to comment or review the proposed rule. After considering the information and comments submitted, the Federal Register can publish the final rule. The public notice from the FDA is also relevant in demonstrating why an applicants condition was not found to be eligible hence placing on public display in the Dockets Management. Similarly, if a condition is also eligible to be included in the OTC drug system, the time and extent application is also placed on public notice to request the eligible applicant to submit data that will show safety and effectiveness of the OTC drugs. The public notice also acts like an advisory review whereby those interested people who submitted the data are provided with a proposed rulemaking to include the conditions in the monograph. Therefore, all interested people and TEA applicants have an opportunity to comment on FDAs proposed rule through the public notice hence include additional data as required in order to publish a final rule.


U.S. Department of Health and Human Services,. (2011). Guidance for Industry Time and Extent Applications for Nonprescription Drug Products. Retrieved 21 June 2016, from

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The Benefits and Risks Compared to the Traditional Route of Drug Approval. (2021, Mar 19). Retrieved from

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