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117 results found for: fda
The U.S. Food and Drug Administration has made draft guidance available with updated recommendations for good clinical practices (GCPs), which are intended to modernize the clinical trial design and conduct while maintaining data integrity and participant protection. The draft advice […]
This article deals with FDA device approval which Recalls Draeger Medical’s Seattle PAP Plus and Breathing Circuit/Anesthesia Kits due to the risk of loose or detached components restricting breathing support. The use of these devices can result in significant injury […]
Vyjuvek, a herpes simplex virus type 1 (HSV-1) vector-based gene therapy, has been given approval by the FDA for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 […]
The FDA approved Rexulti (brexpiprazole) oral tablets are supplementary approval for the treatment of agitation associated with dementia caused by Alzheimer’s disease. This is the first therapy option for this indication that has FDA Approved. DementiaDementia is a severe and […]
Hearing loss affects 30 million adults in the US, with a high number of people affected by it. Only one-fifth of those who could benefit from a hearing aid seek intervention. To increase access to hearing aids, the FDA Approval […]
The FDA Regulations is adopting further measures to facilitate the use of decentralized clinical trials (DCTs), in which part or all trial-related activities take place at places other than conventional clinical trial sites, including medicines, biologics, and devices. The government […]
The FDA is aware that a number of businesses or individuals provide services linked to FDA rules, such as helping with product approvals or offering guidance on regulatory compliance. It is important to remember that the FDA has not approved […]
This article deals with the first respiratory syncytial virus (RSV) vaccine approved by the FDA Medical Device Regulation. Arexvy is the first respiratory syncytial virus (RSV) vaccine that the FDA Medical Device Regulation has licensed for use in the country. […]
This article deals with the Food and Drug Administration (FDA) regulations warning all healthcare professionals and the general public not to purchase and use unnoticed medical device products such as The FDA regulations confirmed that the above-mentioned medical device product had […]
The Center for Devices and Radiological Health (CDRH) of the FDA has released two final guidance documents to help with transition plans for medical devices that have received Emergency Use Authorizations (EUAs) or fall under specific enforcement guidelines to support […]
