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  • Feature ArticlesFeature Articles

    A regulatory anomaly: The NDA for water

    This is the story of a Code of Federal Regulations monograph for eyewash and a second regulation, which required a new drug application (NDA) for any drug sterilized by gamma irradiation. Both of these regulations did not take into consideration that water is a drug. Therefore, eyewash sterilized by gamma irradiation required an NDA. It took almost 14 years to eliminate the requirement of an NDA for eyewash sterilized by gamma. During this period, the company filed and rec...
  • Feature ArticlesFeature Articles

    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...