【Clinical】What are the points for consideration when reviewing new drug application (NDA) from safety aspect?

刊登日期:2019-11-11  |  點閱次數 : 562 次 

Please reference to「新成份新藥查驗登記療效及安全性之考量重點」
Web site: https://www.fda.gov.tw/tc/siteContent.aspx?sid=9342

  1. Adverse Event (AE) profile and common AEs.
    1. a. If the drug showed a significantly higher AE rate than placebo, a reasonable justification should be provided (e.g., in relation to its pharmacological effect).
    2. b. The time to onset and duration of AE. When is the highest occurrence rate? Tolerable or not? Can be reduced with repeated use? Reversible after drug discontinued? Any dose–effect correlation?
    3. c. Are there any risk factors associated with (i.e., who are the susceptible patients or under what circumstances)? What are the control measures to mitigate the risk?
  2. Evaluate the data of subjects who withdraw from trials owing to:
    1. a. Adverse events;
    2. b. Lack of efficacy.
    An in-depth assessment will be made after comparing with the control group.
  3. Evaluate cases resulting in death or serious AE.
  4. Known drug class effects.
  5. Adverse event of special interest, especially when it resulted in death or life-threatening outcomes. Could it be manageable? Would it cause disability or permanent damage? Could the safety issue impact drug approval?
  6. Proper context of contraindication, warnings, and precautions in the package inserts.



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