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Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry(Final)-2023/03/16
2023-03-16查看详情 > -
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect(Draft)-2023/03/15
2023-03-15查看详情 > -
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 >
