DD final exam

Card Set Information

Author:
Jjanggoo83
ID:
250114
Filename:
DD final exam
Updated:
2013-12-02 13:47:50
Tags:
final
Folders:

Description:
DD final review
Show Answers:

Home > Flashcards > Print Preview

The flashcards below were created by user Jjanggoo83 on FreezingBlue Flashcards. What would you like to do?


  1. Phase of Clinical Development
    • Phase 1- Clinical pharmacology
    • phase 2- therapeutic exploratory 
    • phase3- therapeutic confirmatory 
    • phase 4- therapeutic use
  2. chronic kidney disease? 
    kidney damage
    kidney damage or GFR <60ml/min/1.73m2 for >or= 3 months

    kidney damage is pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies
  3. Types of NDAs
    • new drug application
    • supplemental NDA
    • abbreviated NDA
  4. NDA contents
    NDA contents contains datas

    • Non-clinical reports
    • Clinical study reports
    • CMC reports
    • data summary
  5. Form FDA 356h 
    • Application to Market a New
    • Drug, Biologic or Antibiotic Drug for Human
    • Use

    • Index or table of contents, labeling, summary, chemistry, non-clinical pharmacology and toxicology human pharmacokietics and bioavailability, BE
    • clinical microbiology, clinical, safety update report, statistical, case report tabulations
    • case report forms, patent information, patent certification, establishment description, debarment certification, field copy certification, user fee cover sheet, financial disclosure
  6. FDA form 3542a
    patent information
  7. FDA form 3397
    user fee cover sheet
  8. FDA form 3454 
    financial disclosure 
  9. stability protocol
    • longterm- 25 C at 60% RH
    • intermediate- 30C 65
    • accelerated- 40, 75% 

    undertaken at manufacture batches, to establish or confirm the retest period of a drug or the shelf life of drug product
  10. Summary vs over view. 
    OVerview?
    • critical analysis of available dta
    • connection btw dossier and labeling
    • bridge to the different part of the dossier w/t the development program
    • risk - benefit assessment 
  11. purpose of overviews
    • - provid an evaluation of benefit and risk based on conclusions of the relevant studies
    • - address any specific issues with data, resolved or unresolved
  12. 3 type of supplemental NDA
    • - Labeling (bottle, package insert carton, continer label)
    • - CMC (change in product, production process, quality controls, equpment or facilities)
    • - clinical (additional indication? additional clinical program - clinical report)
  13. Abbreviated NDA? 
    • Generic drugs
    • submission of CMC info,
    • BA & BE study reports
  14. NDA timeline 
    - standard review
    priority review
    • - standard review
    • 60days + 10 months= 12months
    • - priority review
    • 60days + 6months= 8 months
    • - supplemental requiring clinical data
    • - 10months
    • supplemental not requiring clinical data
    • - 6 month
    • Quality supplement 
    • - 4 months
  15. what is required from FDA when review dealdline is reached? 
    • - action letter
    • - not necessarily approval
  16. when refusal to file? 
    if minimum criteria for filing specified in the statute and regulation  are not met , application will not be accepted. 

    • - omission of critical data
    • - omission of a section of NDA under federal regulation
    • - failure to include evidence of effectiveness 
  17. NDA review team
    • CMC reviewer
    • medical reviewer
    • pharmacology reviewer
    • statistical reviewer
    • bioresearch monitoring reviewer
    • microbiology reviewer,
    • biopharmaceutics reviewer

    med, pharm, stat, cmc, biobio micro
  18. NDAconsultation?
    • environmental assessment (EPA)
    • abuse potential - DEA
    • trade name, PI, Patient PI
  19. FDA action letters
    • formerly: approval, approvable, 
    • not approvable

    new regulation: approval, complete response
  20. NDA maintenance
    • * PADER (periodic adverse drug experience reports)
    • - report of ADE at quarterly 
    • 3 yrs from the date of approval of the appliction (w/t 30days of close of the quarter)

    • annual intervals thereafter
    • (w/t 60 days of the anniversary date of approval )

    • * promotional materials  
    • - launch materials must be submitted and prior to use
    • FDA 2253 
    • (subsequent materals submitted at the time of use)

What would you like to do?

Home > Flashcards > Print Preview