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AA

English translation: accelerated approval

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:AA
Selected answer:accelerated approval
Entered by: Veronica Prpic Uhing

02:49 Sep 25, 2005
English language (monolingual) [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: AA
Context: In first-line treatment of KS, liposomal daunorubicin was approved on the basis of a randomized controlled trial comparing it with standard combination chemotherapy using the end points of response rate, TTP, and photographic evidence of cosmesis and other clinical benefit. Liposomal doxorubicin received AA rather than full approval on the basis of tumor response rates that were not accompanied by clinical benefit data. Bexarotene capsules and bexarotene gel received regular approval for treatment of cutaneous manifestations of cutaneous T-cell lymphoma on the basis of a composite assessment of index lesion severity that assessed erythema, scaling, elevation, and lesion pigmentation. Methoxsalen solution was approved for use in a photopheresis system for treatment of skin manifestations of cutaneous T-cell lymphoma on the basis of overall skin score responses and improvement in edema, scaling, and resolution of fissures.

Question: The translation I saw in a Chinese book for ¡°AA¡± does not mean ¡°accelerated approval¡±. Instead it means ¡° conditional approval¡±. Is the translation wrong? Can somebody help provide an explanation? Thanks!
Jianming Sun
Local time: 21:54
accelerated approval
Explanation:
http://www.fda.gov/cder/drug/cancer_endpoints/endpointsArtic...

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Note added at 16 mins (2005-09-25 03:06:01 GMT)
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Here is the explanation why it may be provisional - conditional

..Accelerated Approval or Subpart H Approval is a program described in the NDA regulations that is intended to make promising products for life threatening diseases available on the market on the basis of preliminary evidence prior to formal demonstration of patient benefit. The studies are designed to measure and the FDA evaluation is performed on the basis of a surrogate marker (a measurement intended to substitute for the clinical measurement of interest, usually prolongation of survival) that is considered likely to predict patient benefit. The approval that is granted may be considered a provisional approval with a written commitment to complete clinical studies that formally demonstrate patient benefit. The Federal Register published a discussion of Accelerated Approval with comments. Absent a formal demonstration of patient benefit, a risk benefit assessment cannot be made. Accelerated Approval designation does not necessarily lead to a Priority Review. Applications that were granted approval under the Accelerated Approval or Subpart H program in the Division of Oncology Drug Products are listed here.

http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cf...

http://www.fda.gov/cder/guidance/2197dft.pdf
Selected response from:

Veronica Prpic Uhing
United States
Local time: 08:54
Grading comment
Thanks!
4 KudoZ points were awarded for this answer



SUMMARY OF ALL EXPLANATIONS PROVIDED
5 +4accelerated approval
Veronica Prpic Uhing


  

Answers


9 mins   confidence: Answerer confidence 5/5 peer agreement (net): +4
aa
accelerated approval


Explanation:
http://www.fda.gov/cder/drug/cancer_endpoints/endpointsArtic...

--------------------------------------------------
Note added at 16 mins (2005-09-25 03:06:01 GMT)
--------------------------------------------------

Here is the explanation why it may be provisional - conditional

..Accelerated Approval or Subpart H Approval is a program described in the NDA regulations that is intended to make promising products for life threatening diseases available on the market on the basis of preliminary evidence prior to formal demonstration of patient benefit. The studies are designed to measure and the FDA evaluation is performed on the basis of a surrogate marker (a measurement intended to substitute for the clinical measurement of interest, usually prolongation of survival) that is considered likely to predict patient benefit. The approval that is granted may be considered a provisional approval with a written commitment to complete clinical studies that formally demonstrate patient benefit. The Federal Register published a discussion of Accelerated Approval with comments. Absent a formal demonstration of patient benefit, a risk benefit assessment cannot be made. Accelerated Approval designation does not necessarily lead to a Priority Review. Applications that were granted approval under the Accelerated Approval or Subpart H program in the Division of Oncology Drug Products are listed here.

http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cf...

http://www.fda.gov/cder/guidance/2197dft.pdf


Veronica Prpic Uhing
United States
Local time: 08:54
Specializes in field
Native speaker of: Croatian
PRO pts in category: 20
Grading comment
Thanks!

Peer comments on this answer (and responses from the answerer)
agree  Aleron
1 hr
  -> Thank you!
agree  Michael Barnett: Where "AA" appears the source article, it references a table labelled "Accelerated Approval".
2 hrs
  -> Yes, thank you!
agree  Jörgen Slet
1 day 18 hrs
  -> Thank you!
agree  Saleh Chowdhury, Ph.D.
4 days
  -> Thank you!
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