Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and...
...An appropriate test method is the ASTM F1671-97a Standard Test Method for Resistance of Materials Used.....An appropriate test could consist of submerging a sheath containing a challenge virus plus inserted.....If microbial barrier statements are made, the sponsor would be expected to submit appropriate supporting laboratory test..
http://www.fda.gov/cdrh/ode/guidance/954.html (score=100)

Guidanc for Industry: Container and Closure Integrity Testing in Lieu of...
...test with an appropriate container and closure integrity test in the stability protocol.....specific test period or interval, however, the test should be non-destructive and the.....Consequently, the Agency has determined that it is appropriate that alternative methods..
http://www.fda.gov/cber/gdlns/contain.pdf (score=71)

Class II Special Controls Guidance Document: Medical Washers and Medical...
...use of appropriate test organisms, which are suspended in an organic challenge, for the desired level.....use of appropriate test organisms, which are suspended in an organic challenge, for the desired level.....A specified substrate or carrier upon which a specified number of test organisms are..
http://www.fda.gov/cdrh/ode/guidance/1252.html (score=71)

TESTIMONY D. BRUCE BURLINGTON, M.D. (JULY 23, 1998)
...Drugs of abuse test sample collection systems typically consist of a collection cup or.....Scientific information is freely shared between the two agencies, with appropriate.....It is important to note that this interim policy covers only home test sample collection..
http://www.fda.gov/ola/1998/drugtest.htm (score=70)

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...Effects related to the therapeutic class of the test substance, since the mechanism of.....more than one route may be appropriate if the test substance is intended for..clinical use.....Appropriate negative and positive control groups should be included in the..experimental..
http://www.fda.gov/cder/guidance/4461fnl.pdf (score=42)

Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to...
...licensed HIV-1 antibody test kit and in June 1996, a supplemental Western Blot test to.....appropriate test samples are obtained for all donations included in a pool and..that all.....appropriate clinical specimens to provide final specifications for test kit performance..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=42)

stability guidance -draft
...should be assayed for the chemical content of the preservatives at all appropriate test.....It may be appropriate to test certain products, such as infusion liquids or dermal creams.....warranted, should also be considered through appropriate use test protocols to assure that..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=42)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...Therefore, the finished dosage form manufacturer must perform the appropriate test to characterize the.....There should be good correlation to the dissolution specifications and test results for the biobatch/clinical test batches and.....Therefore, it is appropriate that the physical characteristics of a drug substance be..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=41)

57 FINAL SOFTWARE GUIDANCE COPY 2
...Unit, integration and system level test protocols including pass/fail criteria, test.....This is helpful for determining the appropriate degree of rigor and the kinds of risk.....a software functional test plan with pass/fail criteria, data, and an analysis of the..
http://www.fda.gov/cdrh/ode/57.html (score=41)

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...words, a product is considered safe if it has an appropriate benefit-risk balance for the.....that sponsors test a tool before implementation. Pretesting (or pilot testing) can help to.....appropriate information for consideration in making such a determination include, as..
http://www.fda.gov/cder/guidance/5766dft.pdf (score=41)

Draft Guidance for Industry: Development and Use of Risk Minimization Action...
...words, a product is considered safe if it has an appropriate benefit-risk balance for the.....that sponsors test a tool before implementation. Pretesting (or pilot testing) can help to.....appropriate information for consideration in making such a determination include, as..
http://www.fda.gov/cber/gdlns/riskminim.pdf (score=41)

...If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....appropriate test records) prescription only by specially certified health care practitioners product.....lab test results) 1. Description of RiskMAP Tools FDA plans to develop a RiskMAP Web site..
http://www.fda.gov/cder/guidance/5766dft.doc (score=41)

Draft Guidance for Industry: Development and Use of Risk Minimization Action...
...If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....appropriate test records) prescription only by specially certified health care.....lab test results) Description of RiskMAP Tools.. FDA plans to develop a RiskMAP Web site..
http://www.fda.gov/cber/gdlns/riskminim.htm (score=41)

...If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....appropriate test records) prescription only by specially certified health care practitioners product.....lab test results) 1. Description of RiskMAP Tools FDA plans to develop a RiskMAP Web site..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0188-gdl0001.doc (score=41)

69 - Devices Used for In Vitro Fertilization and Related Assisted...
...IVF media should be issued with labeling which indicates test results for endotoxin.....Water produced in conformance with this standard has properties sufficient and appropriate.....The rationale for requiring information on this test as a special control for class II..
http://www.fda.gov/cdrh/ode/69.html (score=41)

FDA NCI Workshop on Tumor Vaccines
...range which might be appropriate for future studies, 8.. and also to get some sense of the.....test the ability of fibrocytes to prime naive T- 18.. cells in vivo, fibrocytes were.....if appropriate, depending again on your cell line, 21.. we may ask for papilloma virus..
http://www.fda.gov/cber/minutes/tumor121098.pdf (score=41)

Document
...appropriate followup action. available to the general public, FDA intends to continue to.....differences in the sensitivity of the tests, tested by the best available test methods.....establishments that recover, screen, test, communicable diseases, and it provides..
http://www.fda.gov/cber/genadmin/frtissue.pdf (score=41)

...With respect to testing records, the testing laboratory should retain records of the test results and the interpretation of the test.....The movement towards regulating human tissue was accelerated by a hearing on appropriate.....It requires that these tests be done using FDA licensed test kits approved for such use by..
http://www.fda.gov/cber/genadmin/frtissue.txt (score=41)

Attachment E CDRH Final Guidance Cover Sheet
...selection and performance of a variety of test procedures that are widely used and.....appropriate tests that will help provide necessary and sufficient data in support of.....A valid test is one that has been shown to provide accurate, reproducible results that are..
http://www.fda.gov/cdrh/ost/ostggp/immunotox.pdf (score=41)

FR Notice ICH Guidance on Q6A Specifications: Test Procedures and Acceptance...
...For modified-release dosage forms, appropriate test conditions and sampling procedures should be.....Particle size testing may fall into this category, may be performed as an in-process test, or may be performed as a release test.....Where harmonization has been achieved, an appropriate reference to the harmonized..
http://www.fda.gov/cber/gdlns/frich122900.htm (score=41)

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