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法规速递
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Draft Guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment-2023/4/19
2023-04-24查看详情 > -
Draft Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry-2023/4/12
2023-04-13查看详情 > -
Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs-2023/4/12
2023-04-13查看详情 > -
Draft Guidance: Over-the-Counter Monograph Order Requests: Format and Content-2023/4/12
2023-04-13查看详情 > -
Draft Guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making-2023/4/5
2023-04-06查看详情 > -
Draft Guidance: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act-2023/4/5
2023-04-06查看详情 > -
Identification of Medicinal Products — Implementation and Use(Final)-2023/3/31
2023-03-31查看详情 > -
Pharmacogenomic Data Submissions(Draft)-2023/03/17
2023-03-17查看详情 > -
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 >
