New Drug Application, and it Impact Drug Formulation Development in the USA?

The New Drug Application, or NDA, has been a cornerstone of the drug formulation development process in the USA for decades. A key requirement of the US Food and Drug Administration (FDA), the NDA is primarily concerned with the regulation and control of new pharmaceutical products. Since the NDA was first introduced in 1938, each and every new drug has been required to be the subject of a successful NDA before being marketed and sold.

For an NDA to be successful, it must provide enough key information to help the FDA arrive at three key decisions. First, the FDA must be able to determine whether the prospective new drug is both effective and safe and whether the benefits derived from taking it outweigh any possible risks. Second, FDA reviewers need to be able to establish whether the drug's proposed packaging and labeling is appropriate. Lastly, the FDA has to be able to ascertain whether the final step in the development of the drug, the procedure used to make the production drug itself, and the various methods used to maintain the quality of production drugs can adequately preserve the strength, purity and quality of these medicines.

The legal requirement for NDA approval is evidence of a prospective new drug's efficacy through rigorous clinical trials, which run the gamut from tests conducted on volunteers to placebo-controlled, double-blind trials that may be conducted on large groups. In a nutshell, these trials seek to determine whether the benefits of a drug outweigh the risks from taking it and whether the instructions for its use are adequate. This is of prime importance not only for NDA approval but also for the drug formulation development process as a whole, since even the most commonly used drugs can be dangerous if used improperly.

Resource Box: Based in Baltimore, UPM Pharmaceuticals, Inc. is an independent drug development and contract company. UPM offers a comprehensive range of services, from formulation development to stability testing, to clients from the biotechnology and pharmaceutical industries. Please visit UPM-Inc.com or call 410-843-3738 to learn more about the company and its services.