Téléversements
Formal Meetings Between The FDA and Biosimilar Biological Product Sponsors or Applicants November 2015 Procedural 15085fnl 0% ont trouvé ce document utileDesignation of Official Names and Proper Names For Certain Biological Products Propose Rule 2015-21382 0% ont trouvé ce document utileBioeqivalence Recommendations For Specific Products 8857fnl 0% ont trouvé ce document utileBioeqivalence Recommendations For Specific Products 8857fnl PDF 0% ont trouvé ce document utileOff-Patent Off-Exclusivity Drug List With No Generic 2017-10-30 PDF 0% ont trouvé ce document utileMAPP 5240.3 Rev.2 Prioritization of The Review of Original ANDAs, Amendments, and Supplements PDF 0% ont trouvé ce document utileGood ANDA Submission Practices DRAFT January 2018 Generics PDF 0% ont trouvé ce document utileStability Guidance & Draft Q&A Guidance Considerations FDA Small Business WEBINAR 2013-11-04 UCM373234 PDF 0% ont trouvé ce document utileRLD - Reference Standard - BOS Draft Guidance Webinar 1-18-17 PDF 0% ont trouvé ce document utile