In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
The life sciences industry is well positioned for growth in 2025, fueled by strong investor interest and technological advancements, especially in AI. Life sciences venture capital (VC) funding and IPOs have picked up in...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s performance in moving...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more
The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more