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The FDA New Animal Drug Approval Process
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
Jacob Michael Froehlich, Alice Ignaszewski, Anna O’Brien
The approval process for a generic new animal drug is similar to the approval process detailed above (see Overview of the Phased Review Process). Instead of opening an INAD file, the sponsor will open a Generic Investigational New Animal Drug (JINAD) file under which data can be submitted. When a sponsor opens a JINAD file to initiate the phased review process, the appropriate new animal drug that is being copied, referred to as the Reference Listed New Animal Drug (RLNAD), is identified, along with its approved indications. In contrast to the seven technical sections that make up the INAD file, there are six technical sections that make up the JINAD file. The technical sections under a JINAD are: bioequivalence (BE); patent certification and marketing exclusivity; chemistry, manufacturing, and controls (CMC); environmental impact (NV); labeling; and human food safety (HFS) (if applicable). The information required to support the completion of the CMC, NV, and HFS technical sections is the same for both new animal drugs and generic new animal drugs (see New Animal Drugs: Small Molecules, Purified Proteins, and Recombinant Technologies above). Upon completion of the required technical sections for a generic new animal drug, the sponsor will request approval by filing an administrative Abbreviated New Animal Drug Application (ANADA). It should be noted that the TAS and EFF technical sections are not components of an administrative ANADA, as a generic new animal drug is a copy of a new animal drug that has already been demonstrated to be safe and effective. Instead, the BE technical section acts as a link to the TAS and EFF technical sections and is the reason why the application for approval of a generic new animal drug is considered “abbreviated.”
Companion Animal Studies: Slipping Through a Research Oversight Gap
Published in The American Journal of Bioethics, 2018
Rebecca L. Walker, Jill A. Fisher
In the United States, oversight of animal research is typically conducted by institutional animal care and use committees (IACUCs), which are mandated both by the Animal Welfare Act and by the Public Health Service. Yet, this oversight structure generally contains features that may limit the protections that animals receive (Walker 2006). Most relevant for CALS, IACUC review, unlike in human subject research, does not require a risk–benefit analysis of individual animal research protocols (Carbone 2014). While federal funding mechanisms require assessment of the science value of the research, this is not the same as balancing potential (or actual) harms to animals with proposed benefit to animals and humans. Further, for studies that are funded by private sources—as studies like CALS are likely to be—even an impartial science value assessment may be missing. Similarly, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) requires evidence of a “rational basis” to undertake companion animal clinical trials (Hampshire 2003, 193) and subsequent reporting of any adverse experiences, but this also does not amount to a risk–benefit analysis. Further, it is unclear from the case description whether CALS falls under CVM oversight, which is applicable when drug sponsors seek approval for a new animal drug application.