Skip to main content

Currently Skimming:

Appendix B: Recommendations from Related IOM Reports
Pages 279-286

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 279...
... Appendix B Recommendations from Related IOM Reports 
From page 280...
... Guidelines, Standards, Oversight, and Incentives Needed for Biomarker Development 6. overnment agencies and other stakeholders should develop a transpar G ent process to create well-defined consensus standards and guidelines for biomarker development, validation, qualification, and use.
From page 281...
...  APPENDIX B BOX B-2 Summary of Recommendations for The Future of Drug Safety: Promoting and Protecting the Health of the Public Organizational Culture 3.1 he committee recommends that the Food, Drug, and Cosmetics Act T (FDCA) be amended to require that the Food and Drug Administration (FDA)
From page 282...
...  EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS BOX B-2 Continued (a) onduct a systematic, scientific review of the Adverse Event Report C ing System; (b)
From page 283...
...  APPENDIX B BOX B-2 Continued (b) esignating the FDA's Science Board as the extramural advisory D committee to the Chief Scientist; (c)
From page 284...
...  EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS BOX B-2 Continued before and after approval of a new drug, new indication, or new dosage, as well as after identification of new contraindications or patterns of adverse events. The limitations imposed should match the specific safety concerns and benefits presented by the drug product.
From page 285...
... Washing ton, DC: The National Academies Press.


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.