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M PHARM IST YEAR
INDEX Introduction PDUFA legislation & background Goals of PDUFA FDA review process & drug safety.
INTRODUCTION Prescription Drug User Fee Act (PDUFA) ,was a law passed  by the united states congress in 1992, which allow...
PDUFA LEGISLATION &BACKGROUND PDUFA must be reauthorized every 5 years &was    renewed in   1997 (PDUFA 2nd)   2002(PDU...
PDUFA        1st   1992 PDUFA was passed in order to shorten the length of  time from a manufacturer’s submission of NDA ...
PDUFA       2ND    1997 In 1997 reauthorized of PDUFA , congress enticted  stricter performance goals, required increased...
PDUFA       3RD 2002Part of public health & bioterrorism preparedness Act, made appropriation for increased post marketin...
PDUFA       4TH    2007 The FDA requested & received fee increases to cover increased reviewer workload & EXPANDED POST M...
PDUFA       5TH   2012 The pharmaceutical research & manufacturers of  America (Ph RMA) strongly supports reauthorization...
PDUFA 1992 PDUFA required drug sponsors to pay a one time fee  for a new drug application (NDA) 0r a Biological  licensin...
In particular, on or before the actiondate mandatory by PDUFA ,the FDA isexpected to issue one of three outcomeletters-the...
In case of an approved letter; The company has right to market the drug . For an approvable outcome, the NDA/BLA can be ...
GOALS OF PDUFA To review of original new human drug & biological  application. Resubmissions of original application. P...
FDA REVIEW PROCESS & SAFETY Under PDUFA could operate to increase or decrease  drug risk. PDUFA has caused FDA review to...
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Priscription drug user free act......sn

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Transcript of "Priscription drug user free act......sn"

  1. 1. M PHARM IST YEAR
  2. 2. INDEX Introduction PDUFA legislation & background Goals of PDUFA FDA review process & drug safety.
  3. 3. INTRODUCTION Prescription Drug User Fee Act (PDUFA) ,was a law passed by the united states congress in 1992, which allowed the food & drug administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process The Act provided that the FDA was entitled to collect a substantial application fee from dug manufacturers at the time a new drug application (NDA) was submitted, with those funds designated for use only in Center For Drug Evaluation & Research (CDER)or Center For Biologics Evaluation & Research(CBER) drug approval activities.
  4. 4. PDUFA LEGISLATION &BACKGROUND PDUFA must be reauthorized every 5 years &was renewed in 1997 (PDUFA 2nd) 2002(PDUFA 3rd) 2007(PDUFA 4th)& 2012 (PDUFA 5th) On july 9,2012 the president signed into law the food & drug administration safety & innovation act (FDASIA), PDUFA will provide for the continued timely review of new drug & biologic licence application.
  5. 5. PDUFA 1st 1992 PDUFA was passed in order to shorten the length of time from a manufacturer’s submission of NDA or Biologics licence application to an FDA decision. These include application review fees paid by the sponsor for each drug or biological application submitted . Establishment fee paid by manufacturer annually for each of its facilities, &product fees paid annually for each product on the market covered by PDUFA.
  6. 6. PDUFA 2ND 1997 In 1997 reauthorized of PDUFA , congress enticted stricter performance goals, required increased transparency in the drug review process &tried to facilitate better communication b/w drug makers & patient advocacy groups. Congress expanded the scope of the legislation to include the investigation phase of a new drug’s development.
  7. 7. PDUFA 3RD 2002Part of public health & bioterrorism preparedness Act, made appropriation for increased post marketing of new drug & allowed the FDA to review new drug.Drug the period that PDUFA 3rd was in effect the FDA’s requirement that drug companies pay user fees for 50 5(b)(2) application to switch drugs from requiring a prescription to being sold over the counter become a source of controversy.
  8. 8. PDUFA 4TH 2007 The FDA requested & received fee increases to cover increased reviewer workload & EXPANDED POST MARKETING SAFETY INITIATIVES, as well as authority to apply user fees to the monitoring of direct of consumer drug advertising.
  9. 9. PDUFA 5TH 2012 The pharmaceutical research & manufacturers of America (Ph RMA) strongly supports reauthorization of PDUFA . PDUFA can play a critical role in making more life saving medicines available to patient in a timely manner strengthening the scientific base of the FDA.
  10. 10. PDUFA 1992 PDUFA required drug sponsors to pay a one time fee for a new drug application (NDA) 0r a Biological licensing application (BLA) with clinical data. NDA/BLA are assigned a standard or priority status at the time of NDA submission, depending on the agent & potential therapeutic benefits. Under PDUFA, FDA is expected to deliver a complete review of 90% of priority application within 6 months. Correspondingly ,the FDA is expected to review 90% of standard application within 12 months.
  11. 11. In particular, on or before the actiondate mandatory by PDUFA ,the FDA isexpected to issue one of three outcomeletters-the NDA is approvable, ornot -approvable
  12. 12. In case of an approved letter; The company has right to market the drug . For an approvable outcome, the NDA/BLA can be approved if certain deficiencies & issues are appropriately addressed.In case not-approvable letter; The company has not satisfied the FDA’s standard of safety & efficacy with the evidence submitted in its NDA/BLA,
  13. 13. GOALS OF PDUFA To review of original new human drug & biological application. Resubmissions of original application. Provide supplements to approved application. Improve communication & to sets goals for specific kinds of meetings b/w the FDA & drug sponsors.
  14. 14. FDA REVIEW PROCESS & SAFETY Under PDUFA could operate to increase or decrease drug risk. PDUFA has caused FDA review to undertake more risks in order to meet performance targets. PDUFA also produced a large infusion of new resources to evaluate a drugs benefits &risks in a timely manner.
  15. 15. THANK YOU
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