政策声明

美国食品药品监督管理局（FDA）批准了Lipfendra（enlicitide），这是首个口服的前蛋白转化酶枯草杆菌蛋白酶/kexin类型9（PCSK9）抑制剂，作为饮食和运动的辅助手段，用于降低成人高胆固醇血症患者的低密度脂蛋白胆固醇（LDL-C），即“坏”胆固醇。这一批准标志着在高胆固醇治疗领域的重要进展，为患者提供了新的治疗选择，尤其是对于那些难以通过现有治疗方案有效控制胆固醇水平的患者。Lipfendra的口服形式相比现有的注射剂型，更便于患者长期使用和管理。

美国食品药品监督管理局（FDA）宣布公众有机会对机构拟议的信息收集活动发表意见。根据1995年的《文书工作减少法》（PRA），联邦机构必须在《联邦公报》上发布关于每项拟议的信息收集活动的通知，包括对现有信息收集活动的拟议延期，并允许公众在通知发布后60天内发表意见。此通知旨在征求公众对于自愿性国家零售食品监管计划标准的意见。

美国食品药品监督管理局（FDA）正在公告公众有机会对机构拟议的信息收集活动发表评论。根据1995年的《文书工作减少法》（PRA），联邦机构必须在《联邦公报》上发布关于每项拟议的信息收集活动的通知，包括对现有信息收集活动的拟议延期，并允许公众在通知发布后60天内作出评论。此次通知旨在征求公众对医疗器械自愿改进计划相关的信息收集活动的意见。

美国食品药品监督管理局（FDA）宣布就机构提议收集某些信息向公众征求意见。根据1995年《文书工作减少法》（PRA），联邦机构必须在《联邦公报》上发布关于每项提议的信息收集通知，包括对现有信息收集的每项提议延期，并允许公众在通知发布后60天内提出评论。此次通知征求公众对婴儿配方奶粉要求相关的信息收集活动的意见。

美国食品药品监督管理局（FDA）宣布公众有机会对机构拟议的信息收集活动发表评论。根据1995年《文书工作减少法》（PRA），联邦机构必须在《联邦公报》上发布关于每项拟议的信息收集活动的通知，包括对现有信息收集活动的拟议延期，并允许公众在通知发布后60天内发表评论。此次通知旨在征求关于医疗器械不良事件计划（MedSun）的信息收集活动的公众意见，该计划旨在提高医疗产品的安全性，通过监测和分析不良事件数据来识别潜在的安全问题。

美国食品药品监督管理局（FDA）宣布就机构拟议的信息收集活动征求公众意见。根据1995年《文书工作减少法》（PRA），联邦机构必须在《联邦公报》上发布关于每一项拟议的信息收集活动的通知，包括每一项现有信息收集活动的延期，并允许公众在通知发布后60天内提出意见。此次通知旨在征求关于符合性评估计划的认证方案的意见。

美国食品药品监督管理局（FDA）宣布了一项程序，用于向公众发出数据请求，以帮助告知某些未来的非处方药（OTC）专论药物活动，包括开发FDA发起的拟议命令，以修改OTC专论中描述的条件。FDA发布此通知是为了告知公众和相关方其正在实施的数据请求程序。

美国食品药品监督管理局（FDA）宣布了一项名为《外用皮质类固醇：体内生物等效性》的最终行业指南。该指南为提交简化新药申请（ANDA）的申请人提供了关于所有效力级别的外用皮质类固醇的体内药理学方法的建议。这对外用皮质类固醇药物的开发和审批流程具有重要指导意义，特别是对于那些希望确保其产品与已上市药物具有相同疗效的企业。该指南的发布有助于提高药品的质量标准，确保患者能够获得安全有效的治疗选择。

美国食品药品监督管理局（FDA）发布了名为《FDA与非处方药专论的申办者或请求者之间的正式会议》的最终行业指南。该指南为行业提供了关于FDA与非处方药（OTC）专论的申办者或请求者之间正式会议的建议，包括会议的程序、目的、类型以及如何准备和安排会议。这将有助于提高OTC药物开发和监管过程的透明度和效率，对OTC药物市场产生重要影响。

美国食品药品监督管理局（FDA）宣布将举行关于未来致幻药物治疗用途的公开听证会。FDA将与联邦合作伙伴共同举办此次听证会，旨在收集有关在监督和支持环境下使用含有致幻药物成分的药物产品的相关问题的反馈和观点。此次听证会关注致幻药物在治疗精神疾病、疼痛管理等领域的潜力，以及其安全性和监管框架的建立。

美国食品药品监督管理局（FDA）宣布发布名为《致幻药物：临床研究考虑》的最终行业指南。随着致幻药物治疗潜力的兴趣日益增加，设计评估这些化合物的临床试验面临着独特的挑战，FDA制定了此草案指南，以提供给赞助商考虑的基础方面。最终指南提供了关于致幻药物临床研究的一般性考虑，旨在帮助确保研究设计的科学性和合规性，促进安全有效的治疗方案的开发。

美国食品药品监督管理局（FDA）已确定TOVALT ODT (酒石酸唑吡坦) 口崩片，5毫克和10毫克，未因安全或有效性问题而从市场上撤回。这一决定将允许FDA在满足所有其他法律和监管要求的情况下，批准酒石酸唑吡坦口崩片5毫克和10毫克的简化新药申请（ANDA）。这表明酒石酸唑吡坦口崩片仍然被认为是安全有效的，对于仿制药制造商来说是一个积极的信号，可以继续开发和申请该药物的仿制版本。

美国食品药品监督管理局（FDA）宣布将召开一场名为“医疗器械用户费用修正案”的公开会议。会议旨在讨论2028至2032财年医疗器械用户费用修正案（MDUFA）重新授权的建议。MDUFA授权FDA收取费用并用于医疗器械申请的审查过程。当前的MDUFA立法授权将于2027年9月到期。此次会议将影响医疗器械制造商、供应商及相关领域的专业人士，特别是那些计划在上述财年内向FDA提交申请的企业。合规要点包括关注MDUFA重新授权的具体条款、费用结构的变化以及可能对申请审查时间的影响。

美国食品药品监督管理局（FDA）宣布即将召开细胞、组织和基因治疗咨询委员会的公开会议。此次会议将讨论Replimune, Inc.提交的生物制品许可申请（BLA）125827，涉及产品Vusolimogene Oderparepvec。会议将向公众开放，FDA同时设立公共案卷以收集公众意见。此事件主要影响细胞、组织和基因治疗领域，特别是针对新型生物制品的监管评估。中国药企应关注FDA对同类产品的监管动态，以便及时调整研发策略和合规措施。

The Food and Drug Administration (FDA or Agency) has determined that VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/50 milliliters (mL) (1 unit/mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/ 50 mL (1 unit/mL), if all other legal and regulatory requirements are met.

美国食品药品监督管理局（FDA）宣布，根据1995年《文书工作减少法》的要求，已将一项关于医疗器械上市前审批的信息收集提案提交给管理和预算办公室（OMB）进行审查和批准。此次信息收集主要涉及医疗器械的上市前审批流程，可能影响所有需要通过FDA上市前审批的医疗器械产品。中国医疗器械制造商和出口商需关注OMB的最终决定，以确保未来提交的审批文件符合新的信息收集要求，避免审批延迟或拒绝。

美国食品药品监督管理局（FDA）宣布了一项公众评论的机会，涉及该机构提议收集的特定信息。根据1995年的《文书工作减少法》（PRA），联邦机构必须在《联邦公报》上发布关于每项提议的信息收集活动的通知，包括对现有信息收集活动的延期提议，并允许公众在通知发布后60天内提交评论。此次通知旨在征求关于生物制品许可申请（BLA）的程序和要求的相关信息收集活动的意见。

美国食品药品监督管理局（FDA）宣布，根据1995年《文书工作减少法》的规定，已将一项拟议的信息收集活动提交给管理和预算办公室（OMB）进行审查和批准。此次信息收集主要涉及行政实践和程序，以及正式听证会的相关事宜。对于中国药企而言，了解此类信息收集活动及其审查过程，有助于更好地准备与FDA相关的行政程序和可能的听证会，确保在国际市场的合规性。

美国食品药品监督管理局（FDA）于2026年6月24日在联邦公报上发布了一则通知，旨在建立一个加速新药研究（Expedited Investigational New Drug）试点计划，以缩短从药物识别到首次人体研究的时间，同时确保临床试验参与者的安全。此次更正主要是为了修正该文件中的电子邮件地址。该计划将影响新药研发流程，特别是对于希望加快临床试验进程的制药公司。中国药企若有意在美国进行新药临床试验，需关注此试点计划的进展及具体要求。

美国食品药品监督管理局（FDA）宣布撤销34项新药申请（NDAs）的批准，这些申请来自多个不同的申请人。申请人已书面通知FDA，表示这些药品已不再在市场上销售，并请求撤销其申请的批准。此次撤销涉及的药品种类广泛，但具体产品信息未在摘要中详细列出。对于中国药企而言，此信息提醒企业关注自身在美上市药品的市场情况，以及与FDA沟通药品退市的正确流程，确保合规操作。

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYALEV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits c

The Food and Drug Administration (FDA, Agency, or we) is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661 (91 FR. 31462) (the "May 2026 Notice"), by 90 days. The effective date of the May 2026 Notice

The Food and Drug Administration (FDA, Agency, or we) has determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) has determined that prednisolone tablet, 5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials." The guidance is intended to provide recommendations in the application of quantitative systems pharmacology (QSP) modeling when a minimum anticipated biological effect level (MABEL) in first-in- human (FIH), phas

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and replaces the previous draft guidance for industry of the same name issued on December 22, 2023. The draft guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submissions to support regulatory revi

The Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. FDA is requesting information on the potential pilot program which would establish a network of qualified research institutions, such as academic medical c

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." FDA has revised and is reissuing this draft guidance in response to public comments and to changes in drug development by focusing on generating rigorous scientific evidence in the most efficient manner. Advances in our understanding of biological processes and t

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for TAZVERIK (tazemetostat) tablet, 200 milligrams (mg), held by Epizyme, Inc., an Ipsen Company (Epizyme), 1 Main St., Cambridge, MA 02142. Epizyme has voluntarily requested withdrawal of its NDA and has waived the expedited withdrawal procedures.

The Food and Drug Administration (FDA) is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the June 26, 2028, expiration date.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by SpecGx LLC (SpecGx), 385 Marshall Ave., Webster Groves, MO 63119. SpecGx requested withdrawal of approval of this application and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits c

The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older.

The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 20, 2026. The document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 23, 2026. The document indicated that FDA was withdrawing approval of ANDAs 078022 for propranolol hydrochloride (HCl), extended- release capsule, 60 milligrams (mg), 80 mg, 120 mg, and 160 mg, and 090665 for lidocaine HCl, injectab

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.

The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments that appeared in the Federal Register of March 3, 2026. In the notice, FDA requested comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice entitled "Drug Repurposing for Unmet Medical Needs; Request for Information" that appeared in the Federal Register of May 12, 2026 (91 FR 25897). In the notice, FDA requested comments to solicit input on FDA's efforts with respect to drug repurposing to address unmet medical needs. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis.

FDA continues to implement its bold food agenda, with two decisive actions focused on food chemical safety.

FDA announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions.

FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.

FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.