ePT--the Electronic Newsletter of Pharmaceutical Technology
Washington, DC (Jan. 26)-The US Department of Health and Human Services has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).
Washington, DC (Jan. 26)-The US Department of Health and Human Services (HHS, www.hhs.gov) has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).
The new declaration states that manufacturers of vaccines used to prevent potential avian pandemics will receive immunity from product liability claims. According to the Federal Register notice, it is “intended to alleviate certain liability concerns associated with pandemic countermeasures, and, therefore, ensure that the countermeasures are available and can be administered in the event an avian influenza virus spreads and evolves into a strain capable of causing a pandemic.”
With this measure, HHS hopes to encourage the development, clinical testing, manufacture, and distribution of an influenza A vaccine. The declaration went into effect December 1, 2006 and continues through February 28, 2010.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
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.