New drugs are being developed to treat Duchenne Muscular Dystrophy — and many other rare diseases — but the treatments are stalled at the FDA. A new Kickstarter campaign is raising funds to complete a documentary about parents fighting to stop Duchenne Muscular Dystrophy and gain access to potentially life-saving drugs before the disease kills their children.
Last week, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII (Clinical Trial Databases) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. The NIH also announced a proposal to apply the proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that all NIH-funded clinical trials be registered in ClinicalTrials.gov and that summary results be posted to the database in a timely matter. Both documents are open for a 90-day public comment period, and comments will be taken into consideration before final regulations and a final NIH Policy are issued.
Under a proposed rule announced recently by the U.S. Food and Drug Administration (FDA), manufacturers of antibacterial hand soap and body wash will be required to prove their products are safe for long-term use and more effective than plain soap and water in preventing illness and the spread of infection.
The United States government shutdown has slowed or halted federal efforts to protect Americans’ health and safety. Now in its 9th day, the shutdown has impacted food safety efforts, flu programs and disease-tracking, scientific research, and the economic and social well-being of families, children, individuals and communities.