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Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format(Draft)-2023/01/12
2023-01-12查看详情 > -
Format and Content of a REMS Document Guidance for Industry(Final)-2023/01/04
2023-01-04查看详情 > -
Controlled Correspondence Related to Generic Drug Development (Draft)-2022/12/21
2022-12-22查看详情 > -
M11 Clinical Electronic Structured Harmonised Protocol (Draft)-2022/12/21
2022-12-22查看详情 > -
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (Draft)-2022/12/21
2022-12-22查看详情 > -
M11 Template: Clinical Electronic Structured Harmonised Protocol (Draft)-2022/12/21
2022-12-22查看详情 > -
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (Final)-2022/12/15
2022-12-16查看详情 > -
Guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment (Draft)-2022/12/14
2022-12-15查看详情 > -
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (Final)-2022/12/5
2022-12-06查看详情 > -
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (Draft)-2022/12/2
2022-12-05查看详情 >
