National Medical Association - 2000 Annual Convention and Scientific...
...I encourage you to use this database in your practices to look for studies appropriate for your.....appropriate, safe and effective for all Americans, and not just a narrow cut of our.....studies. The history of human experimentation is not all noble. Tuskeegee--it's one word..
http://www.fda.gov/oc/speeches/2000/nationalmedicalassoc.html (score=100)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Moreover, bioequivalency studies are complicated by the fact that only approximately 10-15.....Appropriate acceptance criteria and tests should be instituted to control those drug.....The leak rate test is important in stability studies because it may provide information on..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=58)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Moreover, bioequivalency studies are complicated by the fact that only approximately 10-15.....Appropriate acceptance criteria and tests should be instituted to control those drug.....The leak rate test is important in stability studies because it may provide information on..
http://www.fda.gov/cder/guidance/2180dft.htm (score=58)

2853DFT.PDF
...information required for approval comes from studies not conducted by or for the applicant.....Before submitting the application, the applicant should submit a plan to the appropriate.....replaced FDA's paper NDA policy, which had permitted an applicant to rely on studies..
http://www.fda.gov/cder/guidance/2853dft.pdf (score=58)

...In particular, are the instruments used to evaluate efficacy in these studies appropriate for.....About the same time Merz performed two studies in Europe, large-scale studies in vascular dementia, and again at this.....appropriate way to proceed in this population, again a new population with which we have..
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3979T1.htm (score=58)

...Potency studies should be performed at appropriate intervals as defined in the stability protocol and the results should.....The quality of the final container product placed on stability studies should be.....This guideline is intended to assist the applicant in developing appropriate supporting..
http://www.fda.gov/cber/gdlns/ichq5c071096.txt (score=58)

...Complete studies of safety and effectiveness may not be necessary if appropriate bridging studies are found to.....What type of information can an applicant rely on in an application that is based upon.....Before submitting the application, the applicant should submit a plan to the appropriate..
http://www.fda.gov/cder/guidance/2853dft.doc (score=58)

Applications Covered by Section 505 (b) (2)
...Complete studies of safety and effectiveness may not be necessary if appropriate bridging studies are found to.....What type of information can an applicant rely on in an application that is based upon.....Before submitting the application, the applicant should submit a plan to the appropriate..
http://www.fda.gov/cder/guidance/2853dft.htm (score=58)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...Virus clearance studies should be supported by appropriate statistical analysis.....Reproductive and developmental studies including teratogenicity in an appropriate animal.....Results should be correlated closely with studies of conjugate stability.Studies of the immunoconjugate should be..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=20)

...Statistics Virus clearance studies should be supported by appropriate statistical analysis demonstrating that the study.....Reproductive and developmental studies including teratogenicity in an appropriate animal species should be carried out in.....Initial studies of therapeutic mAb in phase 1 are generally escalation studies of single..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=20)

pediatric rule1994
...on adequate and well-controlled studies in the pediatric population. The pediatric age.....considered differently may be more logical and appropriate. Another comment noted that.....A pediatric use statement may also be based on adequate and well- controlled studies in..
http://www.fda.gov/cder/pediatric/pediatric_rule1994.htm (score=20)

stability guidance -draft
...A systematic approach to photostability testing is recommended covering, as appropriate.....Testing for extractables/leachables on stability studies may be appropriate in situations.....appropriate stability studies on batches of product, and submit the information in an..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=20)

MDI and DPI Drug Products
...For MDI and DPI drug products, certain studies should be performed to determine.....discuss significant departures from the approaches outlined in this guidance with the.....conduct and/or complete prescribed studies on production batches of a drug after approval..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=20)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...Additional evidence from nonclinical or clinical studies is appropriate when quality data are.....Appropriate studies should be considered to confirm that suitable storage conditions and controls are.....Such an evaluation should indicate whether or not confirmatory nonclinical or clinical studies are..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=20)

6003dft.doc
...clinical studies is appropriate when quality data are insufficient to establish.....identify the appropriate FDA staff, call the appropriate number listed on the title page.....knowledge from process development studies, small scale evaluation/validation studies, 331..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=20)

International Conference on Harmonisation; Draft Guidance on Q5E...
...clinical studies is appropriate when quality data are insufficient to establish.....identify the appropriate FDA staff, call the appropriate number listed on the title page.....knowledge from process development studies, small scale evaluation/validation studies, 331..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=20)

Guidance for Industry
...We recommend that phase 2 studies be designed to define the appropriate patient.....When multiple efficacy studies are performed, the studies can be of different designs.6 To.....Because of potential toxicities, this approach may not be appropriate for some drugs nor..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=20)

oncology_wr_template
...Please submit protocols for the appropriate studies to your investigational new drug.....Appropriate sections of the label may be changed to incorporate the findings of the.....Depending upon the outcome of the Phase 1 studies, Phase 2 studies may be initiated, and if necessary..
http://www.fda.gov/cder/pediatric/oncologytemplate.htm (score=19)

Sec. 201.57 CFR
...This subsection of the labeling shall state whether long-term studies in animals have been.....Under this section heading, the labeling shall contain the following subsections as.....If reproduction studies or other data in animals reveal a problem or potential problem..
http://www.fda.gov/cder/pediatric/21cfr20157.htm (score=19)

Pediatric Rule
...this age group with caution and would, whenever appropriate, permit such studies to occur after the product has.....In the development of a new drug or biological product, decisions about appropriate.....based on other information, such as pharmacokinetic studies. Studies may not have to be carried out..
http://www.fda.gov/cder/guidance/pedrule.pdf (score=19)

Las Vegas Injury Lawyer