CONSULTING AND OPINIONS FOR REGULATORY RELATED SERVICES FOR CONTRACEPTIVE RESEARCH

避孕研究监管相关服务的咨询和意见

• 批准号: 10929632
• 负责人: GARY GAMERMAN
• 金额: $ 2.5万
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10929632
• 关键词: Authorization documentation; Award; Biological Sciences; Contraceptive Agents; Contraceptive methods; Contracts; Development; Devices; Funding; Goals; Government; Grant; Knowledge; Persons; Pharmaceutical Preparations; Published Comment; Research; Services; Technology; Woman; authority; design; experience; insight; men; programs; research and development; skills

The Contraception Research Branch has several grant awards and contracts that focus on the development of new contraceptives for men and women – each project has a regulatory requirement. There is a clear benefit to increasing Program’s understanding of these requirements for identified applications and funded awards. There is also a benefit to increasing the field’s knowledge on this topic overall. Only a person skilled in regulatory requirements can provide the critical insight into commenting, designing, packaging, and submitting applications to regulatory bodies can inform Program in making scientific decisions to meet the government’s goal: new contraceptive options for men and women. Mr. Gamerman of Seraphim Life Sciences Consulting has several years’ experience providing opinions for regulatory requirements on developing technologies (e.g., drugs and devices), including contraceptives.

避孕研究处有几项赠款和合同，重点是为男性和女性开发新的避孕药具--每个项目都有管理要求。增加计划对已确定的应用程序和资助奖励的这些要求的了解有明显的好处。从整体上增加该领域对这一主题的了解也是有益的。只有精通法规要求的人员才能在评论、设计、包装和向监管机构提交申请方面提供关键的洞察力，才能为项目做出科学决策提供信息，以实现政府的目标：为男性和女性提供新的避孕选择。Seraphim生命科学咨询公司的Gamerman先生拥有多年为包括避孕药具在内的开发技术(如药物和设备)的监管要求提供意见的经验。