FDA inspections face overhaul
The agency proposes significant revisions to oversight programs for drugs and medical products....
21 July, 2023
FDA
Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage will likely follow
The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease....
06 July, 2023
FDA issues first draft guidance on clinical trials with psychedelic drugs
The U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders....
23 June, 2023
FDA approves MDMA for clinical trial use investigating schizophrenia
Investigators will be assessing the use of the drug to treat impaired social motivation, or asociality, which is a symptom of schizophrenia that can cause significant functional impairment....
09 June, 2023
FDA takes additional steps to advance decentralized clinical trials
The U.S. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites....
02 May, 2023
FDA outlines plan for digital health technologies for clinical trials
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year....
24 March, 2023
Responding to FDA inspections in an era of closer scrutiny
Many changes were made to the FDA's requirements for clinical research during the pandemic, including adoption of decentralized clinical trial elements. How will this affect future inspections....
21 March, 2023