Regulatory Roundup: FDA Issues Final Guidance on How to Comment on Advisory Committee Meetings
FDA Issues Final Guidance on How to Comment on Advisory Committee Meetings
On Dec. 9, 2010, the US Food and Drug Administration issued a final guidance about how to comment during the agency's advisory committee meetings, including the process and timeframe. The guidance finalizes information contained in the 2005 draft document, titled The Open Public Hearing FDA Advisory Committee Meetings Draft Guidance. The new guidance takes effect with meetings held in March 2011.
On Dec. 14, 2010, the US Food and Drug Administration issued a draft guidance for industry on the development of combination drugs. The document provides recommendations for sponsor companies working to codevelop two or more novel drugs to be used in combination totreat a disease or condition. Comments are due within 60 days of the guidance's issue date.
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
