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Titles
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry1
- FDA should further integrate its review of cybersecurity into the premarket review process for medical devices1
- No free lunch?: current challenges facing National School Lunch and School Breakfast Programs1
- Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research1
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff1
- Veterans health care: additional actions could further improve policy management : report to Congressional requesters1