Improving Manufacturing Science Is Key, According to CDER Report
The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) yesterday issued its 2004 report to the nation, citing the center’s key initiatives: improving the science of drug manufacturing, streamlining the path for developing new drugs, and improving methods for identifying and analyzing drug safety issues.
The report says that the center’s overhaul of the pharmaceutical good manufacturing practices “encourages manufacturers to modernize their methods, equipment, and facilities to eliminate both production inefficiencies and undue risks for consumers.” It also says the risk-based approach to inspections makes “better use of limited resources.”
The 66-page report, Improving Public Health through Human Drugs, says CDER developed initiatives to improve drug safety, protect against bioterrorism, and accelerate drug development while maintaining its performance in reviewing new drugs and overseeing the safety of marketed drugs. During 2004, CDER approved 119 new medicines and 380 generic versions of existing drugs, and evaluated more than 400,000 reports of adverse drug events, including more than 20,000 submitted directly by individuals.
–Laura Bush
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.
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.