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Titles
- REMS: FDA's application of statutory factors in determining when a REMS is necessary1
- Recommendation followup: vulnerabilities continue to exist in the HHS small business innovation research program1
- Recommendations for reducing the risk of transfusion-transmitted babesiosis1
- Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff1
- Refuse to accept policy for 510(k)s: guidance for industry and Food and Drug Administration staff1
- Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff1
- Risk evaluation and mitigation strategies: modifications and revisions1