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832 results
  1. ... NHRIC National Health Related Items Code 782 ANADA Abbreviated New Animal Drug application number for the generic drug for MTHSPL 729 ...
  2. ... ambiguity flag AMT AOT uses MeSH term ANADA Abbreviated New Animal Drug application number for the generic drug for MTHSPL ANATOMICAL_COORDINATE Anatomical coordinate ANDA Abbreviated New (Generic) Drug application number for the MTHSPL ...
  3. ... License Application (BLA) New Animal Drug Application (NADA) Abbreviated New Animal Drug Application (ANADA) When searching by application number, users must ...
  4. NLM Digital Collections - Bioanalytical method validation 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
    ... applications (INADs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs), this guidance may apply to blood and ...
  5. NLM Digital Collections - Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during .... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
    ... license application (BLA), new animal drug application (NADA), abbreviated new animal drug application (ANADA)) or a product marketed in conformity with ...
  6. ... by: ANADA — U.S. Food and Drug Administration (FDA) Abbreviated New Animal Drug Application identifier BLA — FDA Biological License Application identifier HCPCS — ...
  7. NLM Digital Collections - Qualification process for drug development tools : guidance for industry and FDA staff 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
    ... 1 B. Acronyms and Abbreviations 2 3 AMQP Animal Model Qualification Program 4 ANDA Abbreviated New Drug Application 5 BEST Biomarkers, EndpointS and other Tools (glossary) ...
  8. NLM Digital Collections - Requesting FDA feedback on combination products : guidance for industry and FDA staff 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020
    ... certain clinical trials, Special Protocol clinical studies, or animal studies Assessment32 Abbreviated New Information on a specific element of generic Controlled Drug Application drug product development and certain Correspondence 38 (ANDA) ...
  9. NLM Digital Collections - Generic drug development : stakeholders’ views of risk evaluation and mitigation strategies ... 
    Publication: Washington, DC : United States Government Accountability Office, October 2019
    ... on FDA’s review and approval of an abbreviated new drug application. Generic drug applications are called “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and ...
  10. ... et al., ed. Biology of radia- tion carcinogenesis. New York, Raven Press, 1976. QZ 202 ... Food and Drug AdminLsLration, 1976. WN 440 A652 1975. Biological and ...
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