Regulatory Roundup: EMEA Reminds Industry of e-CTD Deadline
The European Medicines Agency issued a reminder about the Jan. 1, 2010 deadline for e-CTD submissions.
The European Medicines Agency (EMEA) has issued a reminder that the electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from Jan. 1, 2010. The mandate is part of EMEA's phased introduction of e-CTDs into the centralized procedure. The agency first began accepting electronic-only submissions, with no additional requirements for paper copies, in July 2008, and on Jan. 1, 2009, EMEA strongly recommended that all submissions be electronic.
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.
