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Final Guidance: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health -2023/9/20
2023-09-21查看详情 > -
Draft Guidance: Regulatory Considerations for Prescription Drug Use-Related Software-2023/9/18
2023-09-19查看详情 > -
Draft Guidance: Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence-2023/9/18
2023-09-19查看详情 > -
Draft Guidance: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)-2023/9/15
2023-09-19查看详情 > -
Draft Guidance: Labeling for Biosimilar and Interchangeable Biosimilar Products-2023/9/15
2023-09-19查看详情 > -
Final Guidance: Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry-2023/9/14
2023-09-15查看详情 > -
Final Guidance: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products-2023/9/8
2023-09-14查看详情 > -
Final Guidance: Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment-2023/9/1
2023-09-04查看详情 > -
Draft Guidance: Post-Warning Letter Meetings Under GDUFA-2023/9/1
2023-09-04查看详情 > -
Final Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products-2023/8/30
2023-09-01查看详情 >
