stening session on Amendments to the International Health Regulations (2005). HHS is charged with leading U.S. participation in the Working Group on the Amendments to the International Health Regulations (2005) and will convene a stakeholder listening session on June 9, 2023. The listening session is designed to seek input from stakeholders and subject-matter experts on these proposals and to help inform and prepare the U.S. government for engagement with the Working Group on the Amendments to the International Health Regulations (2005).June 9, 2023: FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss supplemental BLA 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of early Alzheimer’s disease. This product was approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) for the treatment of Alzheimer’s disease. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The committee will discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement 4384-1.June 14, 2023: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH). The agenda will include discussions on the following: work group and subcommittee reports; an update on the status of Special Exposure Cohort (SEC) petitions; and plans for the August 2023 ABRWH meeting.June 16, 2023: NIH announced a public meeting of the Clinical Center Research Hospital Board (CCRHB). The meeting agenda will include NIH and Clinical Center (CC) leadership announcements, updates on recent CC activities and organizational priorities, and other CCRHB business.June 22, 2023: CMS announced a public meeting regarding new and recon

In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly referred to as “accelerated approval,” are located in Subpart H (21 C.F.R. § 314.500) of FDA’s drug regulations, and in Subpart E (21 C.F.R. § 601.40) of the Agency’s biologics regulations. If a product meets these criteria, then FDA may grant marketing approval based: (1) on a demonstrated effect on a “surrogate endpoint” and a sponsor’s commitment to complete with “due diligence” the required postmarketing studies to demonstrate the product’s clinical benefits; or (2) on restrictions to assure safe use (that is, when FDA determines that a drug can be used safely only if distribution or use is modified or restricted).

In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly referred to as “accelerated approval,” are located in Subpart H (21 C.F.R. § 314.500) of FDA’s drug regulations, and in Subpart E (21 C.F.R. § 601.40) of the Agency’s biologics regulations. If a product meets these criteria, then FDA may grant marketing approval based: (1) on a demonstrated effect on a “surrogate endpoint” and a sponsor’s commitment to complete with “due diligence” the required postmarketing studies to demonstrate the product’s clinical benefits; or (2) on restrictions to assure safe use (that is, when FDA determines that a drug can be used safely only if distribution or use is modified or restricted, e.g., THALOMID (thalidomide)).