FDA Seeks Best Practices for Advisory Committee Meetings
The US Food and Drug Administration?s (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process.
The US Food and Drug Administration's (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process. Senior managers from CDER's Advisors and Consultants staff will lead the assessment, examining current practices for nominating members, choosing consultants with appropriate expertise, developing competing-products lists, screening for conflicts of interest, engaging special government employees outside of advisory-committee meetings, and other areas.
Advisory committees are established to provide expert, independent advice on complex scientific issues FDA must consider when making regulatory decisions. The review is expected to take one year and is part of FDA's larger effort to modernize approaches to managing the new-drug review process.
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.
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.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
