This article was originally published in Pharmaceutical Approvals Monthly
FDA's Arthritis Advisory Committee will review the lupus agent prasterone at its March 13-14 meeting. The NDA, submitted Sept. 26, is receiving a priority review. Watson has North American marketing rights to the agent under a November agreemen
You may also be interested in...
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.
As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.