In a tumultuous journey marked by setbacks and delays, Stealth’s drug for Barth syndrome faced initial denial by the FDA, only to later gain momentum with a favorable vote from an advisory committee. Despite this positive development, subsequent missed deadlines by the FDA have raised concerns about the impact of job cuts on the approval […]
Category: FDA Advisory
FDA, CDC Actions Impact COVID-19 Vaccine Coverage
In a commentary by FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, the FDA’s approach to Covid-19 vaccines balances regulatory flexibility with gold-standard science. Trials will focus on high and low-risk individuals, shaping future FDA decisions and meeting healthcare provider and public needs. This strategy aims to ensure vaccine safety and efficacy […]
Understanding FDA Advisory Process
The FDA approval process in the United States, overseen by the Food and Drug Administration (FDA), is intricate and involves input from various individuals with diverse expertise. The FDA advisory committee plays a crucial role in evaluating the safety and efficacy of new drugs and medical devices before they are approved for market distribution. This […]
