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Titles
- Considerations for the development of dried plasma products intended for transfusion1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Evaluation of devices used with regenerative medicine advanced therapies1
- Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations1
- Risk evaluation and mitigation strategies: modifications and revisions1
- Safety and performance based pathway: guidance for industry and Food and Drug Administration1
- Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research1