We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Senators from both sides of the aisle pressed insulin makers and pharmacy benefit managers (PBM) on the drug’s high cost during a committee hearing Wednesday, where the two groups accused each other of driving up costs and lawmakers often appeared baffled by the opaque schemes of drug pricing. Read More
Despite the FDA’s lingering concerns over study data, a 17-member advisory committee unanimously supported Perrigo’s bid to switch its progestin-only oral contraceptive Opill (norgestrel 0.075 mg) from prescription to OTC. Read More
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 $1 billion payout. Read More
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 before resuming drug exports to the U.S. Read More
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 analysis. Read More
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 glycol (EG), to combat a rise in fatal consumer poisonings. Read More
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 and goals. Read More
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. Read More
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 committee meeting this week. Read More
A new document from the Medical Device Single-Audit Program (MDSAP) outlines the program’s plan for implementing its Quality Management System (QMS) guidance on how to design, strengthen and develop quality management processes, products, outcomes and services. Read More