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Draft Guidance: E6(R3) GOOD CLINICAL PRACTICE (GCP)-2023/6/6
2023-06-09查看详情 > -
Final Guidance: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions-2023/6/5
2023-06-06查看详情 > -
Final Guidance: Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals-2023/6/2
2023-06-05查看详情 > -
Guidance for Industry - Migraine: Developing Drugs for Preventive Treatment Drug Trials Snapshot: PYRUKYND-2023/6/1
2023-06-02查看详情 > -
Final Guidance: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products-2023/5/25
2023-05-30查看详情 > -
Draft Guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information-2023/5/24
2023-05-25查看详情 > -
Final Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers-2023/5/24
2023-05-25查看详情 > -
Draft Guidance: Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act-2023/5/17
2023-05-18查看详情 > -
Draft Guidance: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations-2023/5/17
2023-05-18查看详情 > -
Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices-2023/5/2
2023-05-04查看详情 >
