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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
