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Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers(Draft)-2023/03/15)
2023-03-15查看详情 > -
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens(Draft)-2023/03/01
2023-03-01查看详情 > -
Q13 Continuous Manufacturing of Drug Substances and Drug Products(Final)-2323/03/01
2023-03-01查看详情 > -
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment(Draft)-2023/02/24
2023-02-24查看详情 > -
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA(Draft)-2023/02/17
2023-02-17查看详情 > -
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms(Draft)-2023/01/31
2023-01-31查看详情 > -
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products(Draft)-2023/01/31
2023-01-31查看详情 > -
Acromegaly: Developing Drugs for Treatment(Draft)-2023/01/30
2023-01-30查看详情 > -
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry(Final)-2023/01/23
2023-01-23查看详情 > -
Mpox: Development of Drugs and Biological Products; Guidance for Industry(Draft)-2023/01/19
2023-01-19查看详情 >
