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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:21945Orig1s000MICROBIOLOGY REVIEW(S)Product Quality Microbiology Review 18 December 2008 NDA: 21945/BC Drug Product Name Proprietary: Festival
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How to fill out confirmatory study of 17p

01
Familiarize yourself with the protocol and requirements for the confirmatory study of 17p.
02
Obtain informed consent from the patient or their legal representative.
03
Collect necessary samples, such as blood or tissue, as specified in the protocol.
04
Follow the designated procedures for processing and analyzing the samples.
05
Record and document all results accurately and according to the study requirements.
06
Communicate any significant findings or deviations from the protocol to the relevant parties.
07
Submit the completed study report and data for review by the appropriate authorities.

Who needs confirmatory study of 17p?

01
Patients diagnosed with chronic lymphocytic leukemia (CLL) who have tested positive for 17p deletion on their initial screening test may require a confirmatory study of 17p.
02
Physicians and researchers involved in the management and study of CLL may also benefit from confirmatory studies of 17p to aid in treatment decisions and research efforts.
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The confirmatory study of 17p is a process of validating the presence of a 17p deletion in a patient's genetic makeup.
Oncologists and geneticists are usually required to file confirmatory studies of 17p.
To fill out a confirmatory study of 17p, one must collect genetic samples from the patient, conduct the necessary tests, and interpret the results accurately.
The purpose of confirmatory study of 17p is to confirm the presence of a 17p deletion, which is often associated with certain types of cancer.
The report on confirmatory study of 17p must include details about the genetic tests conducted, the results obtained, and the interpretation of those results.
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2008 2006 nda microbiologist metcalfe mcvey bc gestiva cytyc hydroxyprogesterone caproate elko sunnyvale llc langille bloomington hussong resubmission 21945orig1s000 approvable approvability antimicrobial n21845r2 b4 microbiologists cci n021945az000 adeza

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