Gilead Sciences has prevailed in what appears to be the first lawsuit filed by the U.S. government against a drugmaker in an attempt to enforce patent rights, dodging an almost…

Multiple unaddressed violations of current good manufacturing practice, FDA regulations and noncompliance with a 2012 consent decree have earned India’s Sun Pharmaceutical a hefty list of corrective actions to complete…

Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause…

Device manufacturers that apply a more risk-based framework to corrective and preventive action (CAPA) plans rather than using the more typical one-size-fits-all approach could see reduction of up to 80…

The FDA has issued a final guidance to help manufacturers prevent the use of glycerin and other high-risk drug components contaminated with the toxic substances diethylene glycol (DEG) or ethylene…

The Veteran’s Health Administration (VHA), working with the FDA and several other agencies, has launched a challenge for the scientific and data analytics communities to develop AI and machine learning…

CDER’s Office of Pharmaceutical Quality (OPQ) Director Mike Kopcha leads an office of more than 1,300 staff involved in assessing drug marketing applications. FDAnews asked him about OPQ’s challenges, priorities…

As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

Use of ethylene oxide (EtO) for medical device sterilization is safe for employees, neighbors and communities, and is the only viable method for many of the 20 billion devices it…

The rising obesity rate in the U.S. could foil Perrigo’s bid to offer the U.S.’s first OTC oral contraceptive, according to FDA briefing documents in advance of a two-day advisory…