处方药推广办公室（OPDP）指标
正文 · 中文译文
处方药推广办公室（OPDP）指标 药物评价与研究中心（CDER） CDER办公室与部门 CDER倡议 加速罕见病治愈（ARC）计划 CDER临床试验创新中心（C3TI） CDER真实世界证据创新中心（CCRI） 人工智能用于药物开发 CDER定量医学卓越中心（QM CoE） CDER联系信息 CDER政策与程序手册 | MAPP 关于CDER的常见问题 报告与预算 | CDER 本页面跟踪有关处方药推广传播的某些关键指标。OPDP跟踪每月在45天内完成的核心上市审查的数量和百分比，即对FDA批准新药（或批准药物新用途）后公司向医疗专业人员和消费者传播的初始推广材料的审查。本页面还显示关于潜在虚假或误导性推广的投诉百分比，这些投诉可能来自医疗专业人员、消费者、药物申办者或律师事务所，OPDP在收到后30天内进行初步审查并确认。最后，OPDP还跟踪以2253表格向FDA提交推广传播材料的所需提交数量以及提交材料的总数，因为一次提交可能包含多个推广传播材料。 当月完成的核心初始推广活动材料审查数量 词典：“上市”材料是指企业在FDA批准新药（或批准药物新用途）后向医疗保健专业人员和消费者传播的初始宣传材料。FDA认为，确保企业用于介绍新药的宣传信息准确且均衡至关重要，因为这些信息构成了公众对新药的第一印象。“核心”上市材料是那些包含将在整个上市活动中使用的关键信息的材料，以及所宣传产品其他重要披露内容（如风险信息）的代表性示例。通过及时审查核心上市活动并提供咨询意见，OPDP可以积极影响企业就其新产品传播的初始营销信息，并有助于确保公众获得关于新处方药的准确且均衡的信息。由于这是一项项目措施（即侧重于OPDP项目领域的措施），OPDP外部就上市活动进行咨询所需的时间（如有）已从总审查时间中扣除。因此，该措施反映的是在OPDP内部审查这些材料所需的时间，而非机构总审查时间。 45天内完成的核心上市审查 45天内完成的核心上市审查百分比 2026财年 2025财年 2024财年 2023财年 2022财年 *脚注 FDA的目标是在申办者自愿提交“核心上市”推广材料草案后的45天内对其提供意见。然而，近期一些提交自愿审评的核心上市推广材料草案提出了需要额外审评的复杂问题，导致审评时间超过了45天的目标。尽管某些提交材料的审评时限在近期可能需要超过45天，但FDA正在努力在45天内完成大多数提交材料的审评，并实现与以往相当的总体完成百分比。鼓励申办者如有任何问题联系FDA，并暂时为其材料留出额外的审评时间。 在收到投诉后30天内初步审评并确认收到的投诉百分比 说明：OPDP收到来自医疗保健专业人员、消费者、药品申办者和律师事务所的关于可能虚假或误导性推广的投诉。OPDP的目标是在30个日历日内确认收到这些投诉。 30天内确认收到的投诉 30天内确认收到的投诉百分比 2026财年 2025财年 2024财年 2023财年 2022财年 2253表格提交数量和2253材料的数量 说明：申办者在传播推广材料之前，须以2253表格为封面提交这些材料。该指标是对2253表格提交以及这些提交中所含材料的去重计数。 2253表格提交数量 2253材料数量 返回OPDP主页 内容截至： 2026年11月2日 受监管产品 药品
正文 · 英文原文
Office of Prescription Drug Promotion (OPDP) Metrics Center for Drug Evaluation and Research (CDER) CDER Offices and Divisions CDER Initiatives Accelerating Rare disease Cures (ARC) Program CDER Center for Clinical Trial Innovation (C3TI) CDER Center for Real-World Evidence Innovation (CCRI) Artificial Intelligence for Drug Development CDER Quantitative Medicine Center of Excellence (QM CoE) CDER Contact Information CDER Manual of Policies & Procedures | MAPP Frequently Asked Questions about CDER Reports & Budgets | CDER This page tracks certain key metrics regarding prescription drug promotional communications. OPDP tracks the number and percentage of core launch reviews, or reviews of the initial promotional materials that companies disseminate to healthcare professionals and consumers after FDA approves a new drug (or approves a new use for a drug), completed within 45 days for each month. This page also displays the percentage of complaints regarding potentially false or misleading promotion, which may be received from health care professionals, consumers, drug sponsors, or law firms, that OPDP preliminarily reviews and acknowledges within 30 days of receipt. Finally, OPDP also tracks the number of required submissions of promotional communications to FDA on Form 2253 and the total number of submitted materials, as a submission may contain more than one promotional communication. Number of core initial promotional campaign material reviews completed in the month Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals and consumers after FDA approves a new drug (or approves a new use for a drug). FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs. The “core” launch materials are those that contain the key messages that will be used throughout the launch campaign, as well as representative examples of other important disclosures, such as risk information, for the advertised product. By reviewing and providing advisory comments on core launch campaigns in a timely manner, OPDP can positively influence the initial marketing messages that companies disseminate about their new products and help ensure that the public receives accurate and balanced information about new prescription drugs. Because this is a program measure (i.e., a measure that focuses on the OPDP program area), the time required for consultation outside of OPDP (if any) on launch campaigns is being subtracted out of the overall review time. As a result, the measure is reflective of the time it takes to review these materials within OPDP rather than the total agency review time. Completed Core Launch Reviews in 45 Days Percentage Completed Core Launch Reviews in 45 Days FY 2026 FY 2025 FY 2024 FY 2023 FY 2022 *Footnotes The FDA’s goal is to provide comments on draft “core launch” promotional materials within 45 days of the voluntary submission of these materials by sponsors. However, some recent draft core launch promotional materials submitted for voluntary review have raised complex issues that required additional review, resulting in review times that exceeded the 45 day goal. While review timeframes for certain submissions may require more than 45 days in the immediate future, the FDA is working hard to review the majority of submissions within 45 days and to achieve overall completion percentages that are similar to those observed in the past. Sponsors are encouraged to contact the FDA with any questions and to temporarily build in additional review time for their materials. Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt Dictionary: OPDP receives complaints regarding potentially false or misleading promotion from health care professionals, consumers, drug sponsors, and law firms. OPDP's goal is to acknowledge receipt of these complaints within 30 calendar days. Complaints Acknowledged in 30 days Percentage Complaints Acknowledged in 30 days FY 2026 FY 2025 FY 2024 FY 2023 FY 2022 Number of Form 2253 Submissions and 2253 Materials Dictionary: Sponsors are required to submit promotional materials under cover of Form 2253 prior to dissemination. This metric is a distinct count of Form 2253 submissions and materials included within those submissions. Count of Form 2253 Submissions Count of 2253 Materials Return to OPDP Homepage Content current as of: 11/02/2026 Regulated Product(s) Drugs