Regulatory Roundup: FDA Website Provides Information on Drug Shortages
FDA Website Provides Information on Drug Shortages.
As industry witnessed in 2008 with heparin, shortages of certain drugs or drug substances can be hazardous. FDA has a website which lists current drug shortages to keep industry and the public up to date and aware of current stocks. Among the most recent shortages listed are Genentech’s Tamiflu for Oral Suspension and several injections. The information provided on the site is provided voluntarily by manufacturers. Healthcare professionals and patients are also encouraged to notify the agency of shortages at [email protected].
FDA is holding a public workshop Sept. 26, 2011, in Silver Spring, Maryland, on drug shortages to discuss how the Center for Drug Evaluation and Research is addressing the issue, including the causes and impacts of shortages and potential strategies for preventing them in the future.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
