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The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases will hold two virtual meetings in April 2025 to review grant applications. These meetings are closed to the public due to the sensitive nature of the discussions, which could involve confidential information and personal privacy concerns. The first meeting will be held on April 14-15, and the second meeting will take place on April 25. Both meetings will be managed by scientific review officers, Yasuko Furumoto and Chiguang Feng.

The National Institute of Neurological Disorders and Stroke (NINDS) has announced a series of closed meetings as outlined in sections of the Federal Advisory Committee Act. These meetings, occurring from February 12 to March 2, 2021, will review and evaluate grant applications related to neurological disorders. Attendees of the meetings include various scientific review officers and other participants, with all meetings taking place virtually due to their confidential nature. The discussions are closed to the public to protect sensitive information such as trade secrets and personal data.

The National Institutes of Health (NIH) is considering giving EpifiZa Inc., a company based in Canada, an exclusive license for some of its patented technologies. These inventions involve fusion proteins aimed at treating people with short stature due to genetic conditions. Public comments and license applications are being accepted until February 9, 2021. The license is intended to cover worldwide use, focusing on developing and selling treatments for growth-related disorders.

The Food and Drug Administration (FDA) has announced the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee, which will now operate until October 7, 2026. The committee provides expert advice on the safety and effectiveness of drugs used to treat skin and eye conditions, ensuring they are safe for human use. The committee is made up of professionals from various medical fields, including dermatology and ophthalmology, who are selected by the FDA Commissioner. This renewal highlights the FDA's commitment to maintaining expert oversight of drugs within this category.

The Food and Drug Administration (FDA) has proposed a new rule that would require most packaged foods to display a front-of-package (FOP) nutrition label called the Nutrition Info box. This label aims to help consumers quickly find and better understand important nutrition information by providing easy-to-read details about saturated fat, sodium, and added sugars. The new rule also includes updates to regulations for low sodium and low saturated fat claims, and would allow businesses time to adjust, with compliance dates varying based on their annual sales.

The National Advisory General Medical Sciences Council will hold a virtual meeting on May 22, 2025. The meeting is open to the public from 9:30 a.m. to 12:45 p.m. for discussions on various programs, including remarks from the Director of the National Institute of General Medical Sciences (NIGMS). The afternoon session, from 2:00 p.m. to 5:00 p.m., will be closed to review and evaluate grant applications due to privacy and confidentiality concerns. The public can attend the open session online and submit comments in advance if desired.

The Food and Drug Administration (FDA) has issued a priority review voucher to PTC Therapeutics Inc. for their product, KEBILIDI (eladocagene exuparvovec-tneq). This product is designed to treat both adult and pediatric patients with a condition known as aromatic L-amino acid decarboxylase deficiency. The priority review voucher is awarded under the Rare Pediatric Disease program, which encourages the development of treatments for rare diseases affecting children. The FDA is required to announce when such vouchers are given, as part of the criteria set by the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration (FDA) has made changes to rules about animal drugs to update new and existing drug applications, improve readability, and ensure accurate information. These updates reflect approvals, withdrawals, and sponsorship changes for animal drugs from July to September 2024. The FDA also amended its regulations to communicate these changes and to clarify the information about sponsors and conditions of use for drugs. This rule is effective as of December 2, 2024.

The National Heart, Lung, and Blood Institute has announced a series of closed meetings set for April 28, 2025, under the Federal Advisory Committee Act. These meetings are meant to evaluate and review contract proposals and are not open to the public due to the confidential nature of the discussions. All meetings will be held virtually and cover topics related to different emphasis panels, such as the Coordinating Center-JHS and the Community Engagement Center-JHS. Dr. Zhihong Shan is the Scientific Review Officer in charge of these sessions.